{
"info": {
"nct_id": "NCT01132820",
"official_title": "A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND#72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma",
"inclusion_criteria": "* Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required\n\n * Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma\n* All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI\n* Patients must have at least one \"target lesion\" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy\n* Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population\n* Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1\n* Recovery from effects of recent surgery, radiotherapy, or chemotherapy\n\n * Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\n * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\n * Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to registration\n* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen\n* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition: cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa\n\n * Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy\n* Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease; prior hormonal therapy is allowed\n* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl\n* Platelets greater than or equal to 100,000/mcl\n* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) or creatinine (Cr) clearance >= 60 ml/min\n* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)\n* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 2.5 x ULN\n* Alkaline phosphatase less than or equal to 2.5 x ULN\n* Neuropathy (sensory and motor) less than or equal to grade 1\n* Urine protein creatinine (UPC) ratio must be < 1.0 gm\n\n * If UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended\n* Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 x ULN\n* Patients must have an amylase and lipase =< ULN\n* Patients must have a thyroid stimulating hormone (TSH) level and a free thyroxine (free T4) level within the institutional normal limits\n* Patients must have signed an approved informed consent and authorization permitting release of personal health information\n* Patients must meet pre-entry requirements as specified\n* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients who have had prior therapy with cediranib (AZD 2171) or other VEGF pathway-targeted therapy\n* Patient with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy\n* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease\n* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease\n* Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of cediranib (AZD 2171) therapy\n* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels\n* Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases\n* Patients with clinically significant cardiovascular disease; this includes:\n\n * Uncontrolled hypertension defined as systolic > 150 mmHg or diastolic > 100 mmHg despite optimized antihypertensive therapy\n * Myocardial infarction or unstable angina within 6 months of the first date of cediranib (AZD 2171) therapy\n * New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < institutional lower limit of normal (LLN) will be excluded from the study\n * CTCAE grade 2 or greater peripheral vascular disease\n * History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of cediranib (AZD 2171) therapy\n * Mean corrected QT interval (QTc) > 500 msec or history of familial long QT syndrome\n* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies\n* Patients undergoing invasive procedures as defined below:\n\n * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy\n * Major surgical procedure anticipated during the course of the study\n * Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy\n* Patients who are pregnant or nursing",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI",
"criterions": [
{
"exact_snippets": "All patients must have measurable disease",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)",
"criterion": "lesion",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
},
{
"exact_snippets": "each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam",
"criterion": "lesion size (CT, MRI, caliper)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
},
{
"exact_snippets": ">= 20 mm when measured by chest x-ray",
"criterion": "lesion size (chest x-ray)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": "lymph nodes must be >= 15 mm in short axis when measured by CT or MRI",
"criterion": "lymph node size (CT, MRI)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 15,
"unit": "mm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "All patients must have measurable disease",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)",
"criterion": "lesion",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam",
"criterion": "lesion size (CT, MRI, caliper)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
},
{
"exact_snippets": ">= 20 mm when measured by chest x-ray",
"criterion": "lesion size (chest x-ray)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
}
]
},
{
"exact_snippets": "lymph nodes must be >= 15 mm in short axis when measured by CT or MRI",
"criterion": "lymph node size (CT, MRI)",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 15,
"unit": "mm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have at least one \"target lesion\" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
"criterions": [
{
"exact_snippets": "Patients must have at least one \"target lesion\"",
"criterion": "target lesion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented",
"criterion": "tumors within a previously irradiated field",
"requirement": {
"requirement_type": "designation",
"expected_value": "non-target lesions"
}
},
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented",
"criterion": "tumors within a previously irradiated field",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions ... or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
"criterion": "biopsy",
"requirement": {
"requirement_type": "confirmation of persistence",
"expected_value": true
}
},
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions ... or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
"criterion": "biopsy",
"requirement": {
"requirement_type": "time since radiation therapy",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients must have at least one \"target lesion\"",
"criterion": "target lesion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented",
"criterion": "tumors within a previously irradiated field",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions ... or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
"criterion": "biopsy",
"requirement": {
"requirement_type": "confirmation of persistence",
"expected_value": true
}
},
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions ... or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
"criterion": "biopsy",
"requirement": {
"requirement_type": "time since radiation therapy",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "days"
}
}
}
]
}
]
}
]
},
{
"exact_snippets": "tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented",
"criterion": "tumors within a previously irradiated field",
"requirement": {
"requirement_type": "designation",
"expected_value": "non-target lesions"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population",
"criterions": [
{
"exact_snippets": "Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol",
"criterion": "eligibility for higher priority GOG protocol",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
},
{
"exact_snippets": "any active GOG Phase III protocol or Rare Tumor protocol",
"criterion": "active GOG Phase III or Rare Tumor protocol",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "any active GOG Phase III protocol or Rare Tumor protocol",
"criterion": "active GOG Phase III or Rare Tumor protocol",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol",
"criterion": "eligibility for higher priority GOG protocol",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1",
"criterions": [
{
"exact_snippets": "Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2",
"criterion": "GOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1",
"2"
]
}
},
{
"exact_snippets": "patients who have received two prior regimens must have a GOG performance status of 0 or 1",
"criterion": "GOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2",
"criterion": "GOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1",
"2"
]
}
},
"then_criteria": {
"exact_snippets": "patients who have received two prior regimens must have a GOG performance status of 0 or 1",
"criterion": "GOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Recovery from effects of recent surgery, radiotherapy, or chemotherapy",
"criterions": [
{
"exact_snippets": "Recovery from effects of recent surgery",
"criterion": "recovery from surgery",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
},
{
"exact_snippets": "Recovery from effects of recent ... radiotherapy",
"criterion": "recovery from radiotherapy",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
},
{
"exact_snippets": "Recovery from effects of recent ... chemotherapy",
"criterion": "recovery from chemotherapy",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recovery from effects of recent surgery",
"criterion": "recovery from surgery",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
},
{
"exact_snippets": "Recovery from effects of recent ... radiotherapy",
"criterion": "recovery from radiotherapy",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
},
{
"exact_snippets": "Recovery from effects of recent ... chemotherapy",
"criterion": "recovery from chemotherapy",
"requirement": {
"requirement_type": "status",
"expected_value": "recovered"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])",
"criterions": [
{
"exact_snippets": "free of active infection requiring antibiotics",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "exception of uncomplicated urinary tract infection [UTI]",
"criterion": "uncomplicated urinary tract infection (UTI)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "exception of uncomplicated urinary tract infection [UTI]",
"criterion": "uncomplicated urinary tract infection (UTI)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "free of active infection requiring antibiotics",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration",
"criterions": [
{
"exact_snippets": "Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "week"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "week"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to registration",
"criterions": [
{
"exact_snippets": "Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to registration",
"criterion": "prior therapy directed at the malignant tumor",
"requirement": {
"requirement_type": "discontinuation period",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to registration",
"criterion": "prior therapy directed at the malignant tumor",
"requirement": {
"requirement_type": "discontinuation period",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen",
"criterions": [
{
"exact_snippets": "Patients must have had one prior chemotherapeutic regimen",
"criterion": "prior chemotherapeutic regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "regimen"
}
}
},
{
"exact_snippets": "management of endometrial carcinoma",
"criterion": "endometrial carcinoma",
"requirement": {
"requirement_type": "management",
"expected_value": "chemotherapy"
}
},
{
"exact_snippets": "initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy",
"criterion": "initial treatment",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"chemotherapy",
"chemotherapy and radiation therapy",
"consolidation/maintenance therapy"
]
}
},
{
"exact_snippets": "chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen",
"criterion": "chemotherapy with primary radiation",
"requirement": {
"requirement_type": "counted as",
"expected_value": "systemic chemotherapy regimen"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients must have had one prior chemotherapeutic regimen",
"criterion": "prior chemotherapeutic regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "regimen"
}
}
},
{
"exact_snippets": "management of endometrial carcinoma",
"criterion": "endometrial carcinoma",
"requirement": {
"requirement_type": "management",
"expected_value": "chemotherapy"
}
}
]
},
{
"exact_snippets": "initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy",
"criterion": "initial treatment",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"chemotherapy",
"chemotherapy and radiation therapy",
"consolidation/maintenance therapy"
]
}
},
{
"exact_snippets": "chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen",
"criterion": "chemotherapy with primary radiation",
"requirement": {
"requirement_type": "counted as",
"expected_value": "systemic chemotherapy regimen"
}
}
]
}
},
{
"identified_line": {
"line": "* Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, due to the novel nature of biologic compounds, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy",
"criterions": [
{
"exact_snippets": "Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen",
"criterion": "cytotoxic chemotherapy regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "additional"
}
}
},
{
"exact_snippets": "patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy",
"criterion": "enrollment on second-line non-cytotoxic studies",
"requirement": {
"requirement_type": "encouragement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen",
"criterion": "cytotoxic chemotherapy regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "additional"
}
}
},
{
"exact_snippets": "patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy",
"criterion": "enrollment on second-line non-cytotoxic studies",
"requirement": {
"requirement_type": "encouragement",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease; prior hormonal therapy is allowed",
"criterions": [
{
"exact_snippets": "Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease",
"criterion": "non-cytotoxic chemotherapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": false
}
},
{
"exact_snippets": "prior hormonal therapy is allowed",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Patients must have NOT received any non-cytotoxic chemotherapy for management of recurrent or persistent disease",
"criterion": "non-cytotoxic chemotherapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": false
}
}
},
{
"exact_snippets": "prior hormonal therapy is allowed",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl",
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{
"exact_snippets": "Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl",
"criterion": "absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mcl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl",
"criterion": "absolute neutrophil count (ANC)",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelets greater than or equal to 100,000/mcl",
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{
"exact_snippets": "Platelets greater than or equal to 100,000/mcl",
"criterion": "platelets",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mcl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelets greater than or equal to 100,000/mcl",
"criterion": "platelets",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mcl"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) or creatinine (Cr) clearance >= 60 ml/min",
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{
"exact_snippets": "Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
"criterion": "creatinine level",
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"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional ULN"
}
}
},
{
"exact_snippets": "creatinine (Cr) clearance >= 60 ml/min",
"criterion": "creatinine clearance",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
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"requirement_type": "quantity",
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"operator": "<=",
"value": 1.5,
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}
}
},
{
"exact_snippets": "creatinine (Cr) clearance >= 60 ml/min",
"criterion": "creatinine clearance",
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"requirement_type": "quantity",
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"operator": ">=",
"value": 60,
"unit": "ml/min"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)",
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{
"exact_snippets": "Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)",
"criterion": "bilirubin level",
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"requirement_type": "quantity",
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"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Bilirubin less than or equal to 1.5 x upper limit of normal (ULN)",
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"requirement_type": "quantity",
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"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 2.5 x ULN",
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{
"exact_snippets": "Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 2.5 x ULN",
"criterion": "aspartate aminotransferase (AST)",
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"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 2.5 x ULN",
"criterion": "aspartate aminotransferase (AST)",
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"requirement_type": "level",
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"operator": "<=",
"value": 2.5,
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Alkaline phosphatase less than or equal to 2.5 x ULN",
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{
"exact_snippets": "Alkaline phosphatase less than or equal to 2.5 x ULN",
"criterion": "alkaline phosphatase",
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"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Alkaline phosphatase less than or equal to 2.5 x ULN",
"criterion": "alkaline phosphatase",
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"requirement_type": "level",
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"operator": "<=",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Neuropathy (sensory and motor) less than or equal to grade 1",
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{
"exact_snippets": "Neuropathy (sensory and motor) less than or equal to grade 1",
"criterion": "neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Neuropathy (sensory and motor) less than or equal to grade 1",
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"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Urine protein creatinine (UPC) ratio must be < 1.0 gm",
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{
"exact_snippets": "Urine protein creatinine (UPC) ratio must be < 1.0 gm",
"criterion": "UPC ratio",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1.0,
"unit": "gm"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Urine protein creatinine (UPC) ratio must be < 1.0 gm",
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"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 1.0,
"unit": "gm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* If UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended",
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{
"exact_snippets": "UPC ratio >= 1",
"criterion": "UPC ratio",
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"requirement_type": "comparison",
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"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "collection of 24-hour urine measurement of urine protein is recommended",
"criterion": "24-hour urine measurement of urine protein",
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"requirement_type": "recommendation",
"expected_value": true
}
}
]
},
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"operator": ">=",
"value": 1,
"unit": "N/A"
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}
},
"then_criteria": {
"exact_snippets": "collection of 24-hour urine measurement of urine protein is recommended",
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"requirement_type": "recommendation",
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}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 x ULN",
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{
"exact_snippets": "Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN",
"criterion": "international normalized ratio (INR)",
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"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin",
"criterion": "international normalized ratio (INR)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": ""
},
{
"operator": "<=",
"value": 3,
"unit": ""
}
]
}
}
},
{
"exact_snippets": "partial thromboplastin time (PTT) =< 1.5 x ULN",
"criterion": "partial thromboplastin time (PTT)",
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"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
},
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"and_criteria": [
{
"condition": {
"and_criteria": [
{
"exact_snippets": "Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN",
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},
{
"exact_snippets": "partial thromboplastin time (PTT) =< 1.5 x ULN",
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"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
},
"then_criteria": null,
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"operator": ">=",
"value": 2,
"unit": ""
},
{
"operator": "<=",
"value": 3,
"unit": ""
}
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}
}
},
{
"exact_snippets": "partial thromboplastin time (PTT) =< 1.5 x ULN",
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"operator": "<=",
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}
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have an amylase and lipase =< ULN",
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"exact_snippets": "amylase ... =< ULN",
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"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
},
{
"exact_snippets": "lipase =< ULN",
"criterion": "lipase level",
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"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "amylase ... =< ULN",
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"operator": "<=",
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}
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"operator": "<=",
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}
}
]
}
},
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"identified_line": {
"line": "* Patients must have a thyroid stimulating hormone (TSH) level and a free thyroxine (free T4) level within the institutional normal limits",
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{
"exact_snippets": "thyroid stimulating hormone (TSH) level ... within the institutional normal limits",
"criterion": "thyroid stimulating hormone (TSH) level",
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"requirement_type": "range",
"expected_value": "within the institutional normal limits"
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},
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"exact_snippets": "free thyroxine (free T4) level within the institutional normal limits",
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}
}
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"exact_snippets": "thyroid stimulating hormone (TSH) level ... within the institutional normal limits",
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}
},
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"exact_snippets": "free thyroxine (free T4) level within the institutional normal limits",
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"requirement_type": "range",
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}
]
}
},
{
"identified_line": {
"line": "* Patients must have signed an approved informed consent and authorization permitting release of personal health information",
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{
"exact_snippets": "Patients must have signed an approved informed consent",
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"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "authorization permitting release of personal health information",
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"requirement": {
"requirement_type": "authorization",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Patients must have signed an approved informed consent",
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"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "authorization permitting release of personal health information",
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}
]
}
},
{
"identified_line": {
"line": "* Patients must meet pre-entry requirements as specified",
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{
"exact_snippets": "pre-entry requirements",
"criterion": "pre-entry requirements",
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"requirement_type": "N/A",
"expected_value": "as specified"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "pre-entry requirements",
"criterion": "pre-entry requirements",
"requirement": {
"requirement_type": "N/A",
"expected_value": "as specified"
}
}
]
}
},
{
"identified_line": {
"line": "* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception",
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{
"exact_snippets": "Patients of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "negative serum pregnancy test",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "practicing an effective form of contraception",
"criterion": "contraception",
"requirement": {
"requirement_type": "practice",
"expected_value": "effective form"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"condition": {
"exact_snippets": "Patients of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "negative serum pregnancy test",
"criterion": "serum pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "practicing an effective form of contraception",
"criterion": "contraception",
"requirement": {
"requirement_type": "practice",
"expected_value": "effective form"
}
}
]
},
"else_criteria": null
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
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{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
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"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients who have had prior therapy with cediranib (AZD 2171) or other VEGF pathway-targeted therapy",
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{
"exact_snippets": "Patients who have had prior therapy with cediranib (AZD 2171)",
"criterion": "prior therapy with cediranib (AZD 2171)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Patients who have had prior therapy with ... other VEGF pathway-targeted therapy",
"criterion": "prior therapy with other VEGF pathway-targeted therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Patients who have had prior therapy with cediranib (AZD 2171)",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Patients who have had prior therapy with ... other VEGF pathway-targeted therapy",
"criterion": "prior therapy with other VEGF pathway-targeted therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patient with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy",
"criterions": [
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"exact_snippets": "history of other invasive malignancies",
"criterion": "history of other invasive malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "evidence of other malignancy being present within the last three years",
"criterion": "evidence of other malignancy within the last three years",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "previous cancer treatment contraindicates this protocol therapy",
"criterion": "previous cancer treatment contraindication",
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"requirement_type": "contraindication",
"expected_value": false
}
}
]
},
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"condition": {
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"and_criteria": [
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}
},
{
"not_criteria": {
"exact_snippets": "evidence of other malignancy being present within the last three years",
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}
}
}
]
}
]
},
"then_criteria": {
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}
]
}
},
{
"identified_line": {
"line": "* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease",
"criterions": [
{
"exact_snippets": "Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
"criterion": "prior chemotherapy for abdominal or pelvic tumor",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
"criterion": "prior chemotherapy for abdominal or pelvic tumor",
"requirement": {
"requirement_type": "cancer type",
"expected_value": "endometrial cancer"
}
},
{
"exact_snippets": "patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration",
"criterion": "prior adjuvant chemotherapy for localized breast cancer",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "patient remains free of recurrent or metastatic disease",
"criterion": "recurrent or metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"and_criteria": [
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"exact_snippets": "Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
"criterion": "prior chemotherapy for abdominal or pelvic tumor",
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"requirement_type": "time since treatment",
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"operator": "<=",
"value": 3,
"unit": "years"
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}
},
{
"exact_snippets": "Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
"criterion": "prior chemotherapy for abdominal or pelvic tumor",
"requirement": {
"requirement_type": "cancer type",
"expected_value": "endometrial cancer"
}
}
]
}
}
]
},
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration",
"criterion": "prior adjuvant chemotherapy for localized breast cancer",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "patient remains free of recurrent or metastatic disease",
"criterion": "recurrent or metastatic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterions": [
{
"exact_snippets": "serious, non-healing wound",
"criterion": "wound",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "serious, non-healing wound",
"criterion": "wound",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "history of abdominal fistula",
"criterion": "abdominal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterion": "time since condition",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 28,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "serious, non-healing wound",
"criterion": "wound",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "serious, non-healing wound",
"criterion": "wound",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "ulcer",
"criterion": "ulcer",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
"requirement": {
"requirement_type": "healing status",
"expected_value": "non-healing"
}
},
{
"exact_snippets": "bone fracture",
"criterion": "bone fracture",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
}
]
}
]
},
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "history of abdominal fistula",
"criterion": "abdominal fistula",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterion": "time since condition",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 28,
"unit": "days"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels",
"criterions": [
{
"exact_snippets": "active bleeding",
"criterion": "active bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pathologic conditions that carry high risk of bleeding",
"criterion": "pathologic conditions with high risk of bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known bleeding disorder",
"criterion": "bleeding disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "tumor involving major vessels",
"criterion": "tumor involving major vessels",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "active bleeding",
"criterion": "active bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pathologic conditions that carry high risk of bleeding",
"criterion": "pathologic conditions with high risk of bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known bleeding disorder",
"criterion": "bleeding disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "tumor involving major vessels",
"criterion": "tumor involving major vessels",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases",
"criterions": [
{
"exact_snippets": "history or evidence upon physical examination of central nervous system (CNS) disease",
"criterion": "central nervous system (CNS) disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "primary brain tumor",
"criterion": "primary brain tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "seizures not controlled with standard medical therapy",
"criterion": "seizures",
"requirement": {
"requirement_type": "control with standard medical therapy",
"expected_value": true
}
},
{
"exact_snippets": "any brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "history or evidence upon physical examination of central nervous system (CNS) disease",
"criterion": "central nervous system (CNS) disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "primary brain tumor",
"criterion": "primary brain tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "seizures not controlled with standard medical therapy",
"criterion": "seizures",
"requirement": {
"requirement_type": "control with standard medical therapy",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "any brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with clinically significant cardiovascular disease; this includes:",
"criterions": [
{
"exact_snippets": "clinically significant cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "clinically significant cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled hypertension defined as systolic > 150 mmHg or diastolic > 100 mmHg despite optimized antihypertensive therapy",
"criterions": [
{
"exact_snippets": "Uncontrolled hypertension defined as systolic > 150 mmHg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 150,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Uncontrolled hypertension defined as ... diastolic > 100 mmHg",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Uncontrolled hypertension ... despite optimized antihypertensive therapy",
"criterion": "hypertension control",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Uncontrolled hypertension defined as systolic > 150 mmHg",
"criterion": "systolic blood pressure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 150,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Uncontrolled hypertension defined as ... diastolic > 100 mmHg",
"criterion": "diastolic blood pressure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "mmHg"
}
}
}
]
},
{
"exact_snippets": "Uncontrolled hypertension ... despite optimized antihypertensive therapy",
"criterion": "hypertension control",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Myocardial infarction or unstable angina within 6 months of the first date of cediranib (AZD 2171) therapy",
"criterions": [
{
"exact_snippets": "Myocardial infarction ... within 6 months of the first date of cediranib (AZD 2171) therapy",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "unstable angina within 6 months of the first date of cediranib (AZD 2171) therapy",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Myocardial infarction ... within 6 months of the first date of cediranib (AZD 2171) therapy",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "unstable angina within 6 months of the first date of cediranib (AZD 2171) therapy",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction < institutional lower limit of normal (LLN) will be excluded from the study",
"criterions": [
{
"exact_snippets": "New York Heart Association (NYHA) grade II or greater congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NYHA grade"
}
}
},
{
"exact_snippets": "serious cardiac arrhythmia requiring medication",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "serious cardiac arrhythmia requiring medication",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "treatment",
"expected_value": "requiring medication"
}
},
{
"exact_snippets": "women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin)",
"criterion": "prior anthracycline treatment",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"doxorubicin",
"liposomal doxorubicin"
]
}
},
{
"exact_snippets": "ejection fraction < institutional lower limit of normal (LLN)",
"criterion": "ejection fraction",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 0,
"unit": "institutional LLN"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "New York Heart Association (NYHA) grade II or greater congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NYHA grade"
}
}
},
{
"exact_snippets": "serious cardiac arrhythmia requiring medication",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "serious cardiac arrhythmia requiring medication",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "treatment",
"expected_value": "requiring medication"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "women who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin)",
"criterion": "prior anthracycline treatment",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"doxorubicin",
"liposomal doxorubicin"
]
}
},
{
"exact_snippets": "ejection fraction < institutional lower limit of normal (LLN)",
"criterion": "ejection fraction",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 0,
"unit": "institutional LLN"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* CTCAE grade 2 or greater peripheral vascular disease",
"criterions": [
{
"exact_snippets": "CTCAE grade 2 or greater peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "CTCAE grade 2 or greater peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "* History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of cediranib (AZD 2171) therapy",
"criterions": [
{
"exact_snippets": "History of cerebrovascular accident (CVA, stroke)",
"criterion": "cerebrovascular accident (CVA, stroke)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... transient ischemic attack (TIA)",
"criterion": "transient ischemic attack (TIA)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... subarachnoid hemorrhage",
"criterion": "subarachnoid hemorrhage",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "within six months of the first date of cediranib (AZD 2171) therapy",
"criterion": "time since event",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of cerebrovascular accident (CVA, stroke)",
"criterion": "cerebrovascular accident (CVA, stroke)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "within six months of the first date of cediranib (AZD 2171) therapy",
"criterion": "time since event",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "History of ... transient ischemic attack (TIA)",
"criterion": "transient ischemic attack (TIA)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "within six months of the first date of cediranib (AZD 2171) therapy",
"criterion": "time since event",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "History of ... subarachnoid hemorrhage",
"criterion": "subarachnoid hemorrhage",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "within six months of the first date of cediranib (AZD 2171) therapy",
"criterion": "time since event",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Mean corrected QT interval (QTc) > 500 msec or history of familial long QT syndrome",
"criterions": [
{
"exact_snippets": "Mean corrected QT interval (QTc) > 500 msec",
"criterion": "corrected QT interval (QTc)",
"requirement": {
"requirement_type": "mean value",
"expected_value": {
"operator": ">",
"value": 500,
"unit": "msec"
}
}
},
{
"exact_snippets": "history of familial long QT syndrome",
"criterion": "familial long QT syndrome",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Mean corrected QT interval (QTc) > 500 msec",
"criterion": "corrected QT interval (QTc)",
"requirement": {
"requirement_type": "mean value",
"expected_value": {
"operator": ">",
"value": 500,
"unit": "msec"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "history of familial long QT syndrome",
"criterion": "familial long QT syndrome",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients undergoing invasive procedures as defined below:",
"criterions": [
{
"exact_snippets": "Patients undergoing invasive procedures",
"criterion": "invasive procedures",
"requirement": {
"requirement_type": "undergoing",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients undergoing invasive procedures",
"criterion": "invasive procedures",
"requirement": {
"requirement_type": "undergoing",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterions": [
{
"exact_snippets": "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterion": "major surgical procedure",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 28,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterion": "open biopsy",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 28,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
"criterion": "significant traumatic injury",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 28,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
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{
"operator": "<",
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},
{
"and_criteria": [
{
"exact_snippets": "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
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{
"operator": "<",
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}
}
}
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},
{
"and_criteria": [
{
"exact_snippets": "Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of cediranib (AZD 2171) therapy",
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"requirement_type": "time since occurrence",
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{
"operator": "<",
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}
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}
}
}
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}
]
}
},
{
"identified_line": {
"line": "* Major surgical procedure anticipated during the course of the study",
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{
"exact_snippets": "Major surgical procedure anticipated during the course of the study",
"criterion": "major surgical procedure",
"requirement": {
"requirement_type": "anticipated",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Major surgical procedure anticipated during the course of the study",
"criterion": "major surgical procedure",
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}
}
]
}
},
{
"identified_line": {
"line": "* Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
"criterions": [
{
"exact_snippets": "Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
"criterion": "minor surgical procedures",
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"requirement_type": "time since procedure",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
},
{
"exact_snippets": "Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
"criterion": "fine needle aspirates",
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"requirement_type": "time since procedure",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
},
{
"exact_snippets": "Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
"criterion": "core biopsies",
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"requirement_type": "time since procedure",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
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}
}
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},
{
"and_criteria": [
{
"exact_snippets": "Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
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}
}
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},
{
"and_criteria": [
{
"exact_snippets": "Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of cediranib (AZD2171) therapy",
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"operator": "<=",
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}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients who are pregnant or nursing",
"criterions": [
{
"exact_snippets": "Patients who are pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "nursing",
"criterion": "nursing",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patients who are pregnant",
"criterion": "pregnancy",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "nursing",
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"requirement_type": "presence",
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required",
"criterions": [
{
"exact_snippets": "recurrent or persistent endometrial carcinoma",
"criterion": "endometrial carcinoma",
"requirement": {
"requirement_type": "status",
"expected_value": [
"recurrent",
"persistent"
]
}
},
{
"exact_snippets": "refractory to curative therapy or established treatments",
"criterion": "endometrial carcinoma",
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"requirement_type": "treatment response",
"expected_value": "refractory"
}
},
{
"exact_snippets": "histologic confirmation of the original primary tumor is required",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "recurrent or persistent endometrial carcinoma",
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"recurrent"
]
}
},
{
"exact_snippets": "refractory to curative therapy or established treatments",
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}
]
},
{
"and_criteria": [
{
"exact_snippets": "persistent endometrial carcinoma",
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]
}
},
{
"exact_snippets": "refractory to curative therapy or established treatments",
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}
}
]
}
]
},
{
"exact_snippets": "histologic confirmation of the original primary tumor is required",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
"criterions": [
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
"criterion": "histologic epithelial cell types",
"requirement": {
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]
}
}
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},
"logical_structure": {
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{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
"criterion": "histologic epithelial cell types",
"requirement": {
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}
},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
"criterion": "histologic epithelial cell types",
"requirement": {
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}
},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
"criterion": "histologic epithelial cell types",
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},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
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},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
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},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
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}
},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
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}
},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
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}
},
{
"exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma",
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}
}
]
}
},
{
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"line": "* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition: cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa",
"criterions": [
{
"exact_snippets": "Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen",
"criterion": "cytotoxic regimen",
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"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "additional"
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}
},
{
"exact_snippets": "cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells",
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"mitotic apparatus"
]
}
},
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"exact_snippets": "resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa",
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]
}
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},
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"and_criteria": [
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"or_criteria": [
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"exact_snippets": "cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells",
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"exact_snippets": "cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells",
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]
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]
},
{
"or_criteria": [
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"exact_snippets": "resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa",
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}
},
{
"exact_snippets": "resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa",
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}
}
]
}
]
}
}
],
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{
"identified_line": {
"line": "* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease",
"criterions": [
{
"exact_snippets": "Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
"criterion": "prior radiotherapy to abdominal cavity or pelvis",
"requirement": {
"requirement_type": "treatment exclusion",
"expected_value": true
}
},
{
"exact_snippets": "Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
"criterion": "prior radiotherapy to abdominal cavity or pelvis",
"requirement": {
"requirement_type": "time frame",
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{
"operator": "<=",
"value": 3,
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}
]
}
}
},
{
"exact_snippets": "prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration",
"criterion": "prior radiation for localized cancer of the breast, head and neck, or skin",
"requirement": {
"requirement_type": "treatment permission",
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}
},
{
"exact_snippets": "prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration",
"criterion": "prior radiation for localized cancer of the breast, head and neck, or skin",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 3,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "the patient remains free of recurrent or metastatic disease",
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}
}
]
},
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"exact_snippets": "failed",
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}
}
},
{
"identified_line": {
"line": "* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies",
"criterions": [
{
"exact_snippets": "known hypersensitivity to Chinese hamster ovary cell products",
"criterion": "hypersensitivity to Chinese hamster ovary cell products",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "known hypersensitivity to ... recombinant human or humanized antibodies",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"or_criteria": [
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"exact_snippets": "known hypersensitivity to Chinese hamster ovary cell products",
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}
},
{
"exact_snippets": "known hypersensitivity to ... recombinant human or humanized antibodies",
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"requirement": {
"requirement_type": "presence",
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}
}
]
}
}
],
"failed_miscellaneous": []
}