{
"info": {
"nct_id": "NCT04954820",
"official_title": "A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor",
"inclusion_criteria": "* Age ≥ 18 years,\n* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),\n* Patient previously treated with 4 cycles of Lutathera® (defined as \"First PRRT\"),\n* Disease control after \"First PRRT\" ≥ 12 months,\n* Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,\n* Decision of retreatment with Lutathera® (defined as \"Second PRRT\") validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,\n* ECOG performance status 0-2,\n* Life expectancy ≥ 6 months as prognosticated by the physician,\n* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (>= liver of surrounding tissue),\n* Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,\n* Adequate bone marrow reserve (Hb > 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³),\n* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),\n* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,\n* Patient´s signed written informed consent,\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\n* Affiliation to the French Social Security System\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patient who did not respond (no CR, PR or SD) to \"first PRRT\".\n* Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1,\n* Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,\n* Pancreatic NET,\n* NeuroEndocrine Carcinoma,\n* Prior external beam radiation therapy to more than 25% of the bone marrow,\n* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN or ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN),\n* Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range,\n* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,\n* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,\n* Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)\n* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),\n* Pregnancy or breast feeding,\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results,\n* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,\n* Concomitant participation or participation within the last 30 days in another clinical trial,\n* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.\n* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age ≥ 18 years,",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),",
"criterions": [
{
"exact_snippets": "Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET)",
"criterion": "intestinal neuroendocrine tumors (NET)",
"requirement": {
"requirement_type": "histological proof",
"expected_value": true
}
},
{
"exact_snippets": "Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET)",
"criterion": "intestinal neuroendocrine tumors (NET)",
"requirement": {
"requirement_type": "grade",
"expected_value": [
"G1",
"G2"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET)",
"criterion": "intestinal neuroendocrine tumors (NET)",
"requirement": {
"requirement_type": "histological proof",
"expected_value": true
}
},
{
"exact_snippets": "Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET)",
"criterion": "intestinal neuroendocrine tumors (NET)",
"requirement": {
"requirement_type": "grade",
"expected_value": [
"G1",
"G2"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Patient previously treated with 4 cycles of Lutathera® (defined as \"First PRRT\"),",
"criterions": [
{
"exact_snippets": "Patient previously treated with 4 cycles of Lutathera®",
"criterion": "treatment with Lutathera®",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 4,
"unit": "cycles"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient previously treated with 4 cycles of Lutathera®",
"criterion": "treatment with Lutathera®",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 4,
"unit": "cycles"
}
}
}
]
}
},
{
"identified_line": {
"line": "* ECOG performance status 0-2,",
"criterions": [
{
"exact_snippets": "ECOG performance status 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG performance status 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy ≥ 6 months as prognosticated by the physician,",
"criterions": [
{
"exact_snippets": "Life expectancy ≥ 6 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy ≥ 6 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (>= liver of surrounding tissue),",
"criterions": [
{
"exact_snippets": "Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion",
"criterion": "SSTRi+ disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion",
"criterion": "SSTRi+ disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 months prior to inclusion"
}
},
{
"exact_snippets": "PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide",
"criterion": "imaging method",
"requirement": {
"requirement_type": "allowed methods",
"expected_value": [
"PET imaging (68Ga-based SSTR analogues)",
"scintigraphy imaging: 111In-pentetreotide",
"scintigraphy imaging: 99mTc-octreotide"
]
}
},
{
"exact_snippets": "At least 90% of lesions must be positive for SSTRi",
"criterion": "lesion positivity for SSTRi",
"requirement": {
"requirement_type": "percentage",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "%"
}
}
},
{
"exact_snippets": "At least 90% of lesions must be positive for SSTRi",
"criterion": "lesion positivity for SSTRi",
"requirement": {
"requirement_type": "positivity",
"expected_value": true
}
},
{
"exact_snippets": "significant uptake (>= liver of surrounding tissue)",
"criterion": "uptake level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "liver of surrounding tissue"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion",
"criterion": "SSTRi+ disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion",
"criterion": "SSTRi+ disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 months prior to inclusion"
}
}
]
},
{
"exact_snippets": "PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide",
"criterion": "imaging method",
"requirement": {
"requirement_type": "allowed methods",
"expected_value": [
"PET imaging (68Ga-based SSTR analogues)",
"scintigraphy imaging: 111In-pentetreotide",
"scintigraphy imaging: 99mTc-octreotide"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "At least 90% of lesions must be positive for SSTRi",
"criterion": "lesion positivity for SSTRi",
"requirement": {
"requirement_type": "percentage",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "%"
}
}
},
{
"exact_snippets": "At least 90% of lesions must be positive for SSTRi",
"criterion": "lesion positivity for SSTRi",
"requirement": {
"requirement_type": "positivity",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "significant uptake (>= liver of surrounding tissue)",
"criterion": "uptake level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "liver of surrounding tissue"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,",
"criterions": [
{
"exact_snippets": "Measurable disease per RECIST 1.1",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "standard",
"expected_value": "RECIST 1.1"
}
},
{
"exact_snippets": "on CT/MRI scans",
"criterion": "imaging modality",
"requirement": {
"requirement_type": "type",
"expected_value": [
"CT",
"MRI"
]
}
},
{
"exact_snippets": "at least 1 lesion with ≥ 1 cm in longest diameter",
"criterion": "lesion size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "≥ 2 radiological tumors lesions in total",
"criterion": "number of tumor lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lesions"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Measurable disease per RECIST 1.1",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "standard",
"expected_value": "RECIST 1.1"
}
},
{
"exact_snippets": "on CT/MRI scans",
"criterion": "imaging modality",
"requirement": {
"requirement_type": "type",
"expected_value": [
"CT",
"MRI"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "at least 1 lesion with ≥ 1 cm in longest diameter",
"criterion": "lesion size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "≥ 2 radiological tumors lesions in total",
"criterion": "number of tumor lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lesions"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Adequate bone marrow reserve (Hb > 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³),",
"criterions": [
{
"exact_snippets": "Adequate bone marrow reserve (Hb > 8 g/dl",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 8,
"unit": "g/dl"
}
}
},
{
"exact_snippets": "Adequate bone marrow reserve ... neutrophils ≥ 1500/mm³",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm³"
}
}
},
{
"exact_snippets": "Adequate bone marrow reserve ... platelets ≥ 80 000/mm³",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80000,
"unit": "mm³"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate bone marrow reserve (Hb > 8 g/dl",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 8,
"unit": "g/dl"
}
}
},
{
"exact_snippets": "Adequate bone marrow reserve ... neutrophils ≥ 1500/mm³",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm³"
}
}
},
{
"exact_snippets": "Adequate bone marrow reserve ... platelets ≥ 80 000/mm³",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80000,
"unit": "mm³"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),",
"criterions": [
{
"exact_snippets": "Negative pregnancy test in women of childbearing potential",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "Women who have no reproductive potential are postmenopausal women",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "Women who have no reproductive potential are ... women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "status",
"expected_value": "permanent sterilization"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Negative pregnancy test in women of childbearing potential",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion)",
"criterion": "β-HCG dosage timing",
"requirement": {
"requirement_type": "timing",
"expected_value": "≤ 4 days before inclusion"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Women who have no reproductive potential are postmenopausal women",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "Women who have no reproductive potential are ... women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "status",
"expected_value": "permanent sterilization"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,",
"criterions": [
{
"exact_snippets": "Effective contraception in men or women of childbearing or pre-menopausal age",
"criterion": "contraception",
"requirement": {
"requirement_type": "effectiveness",
"expected_value": true
}
},
{
"exact_snippets": "men or women of childbearing or pre-menopausal age",
"criterion": "age group",
"requirement": {
"requirement_type": "description",
"expected_value": [
"childbearing",
"pre-menopausal"
]
}
},
{
"exact_snippets": "up to a minimum of 6 months following the end of treatment",
"criterion": "contraception duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Effective contraception in men or women of childbearing or pre-menopausal age",
"criterion": "contraception",
"requirement": {
"requirement_type": "effectiveness",
"expected_value": true
}
},
{
"exact_snippets": "men or women of childbearing or pre-menopausal age",
"criterion": "age group",
"requirement": {
"requirement_type": "description",
"expected_value": [
"childbearing",
"pre-menopausal"
]
}
}
]
},
{
"exact_snippets": "Effective contraception in men or women of childbearing or pre-menopausal age",
"criterion": "contraception",
"requirement": {
"requirement_type": "effectiveness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "up to a minimum of 6 months following the end of treatment",
"criterion": "contraception duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient´s signed written informed consent,",
"criterions": [
{
"exact_snippets": "Patient´s signed written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient´s signed written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,",
"criterions": [
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plan",
"criterion": "compliance with treatment plan",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plan",
"criterion": "compliance with treatment plan",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plan",
"criterion": "compliance with treatment plan",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... treatment plan",
"criterion": "compliance with treatment plan",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... laboratory tests",
"criterion": "compliance with laboratory tests",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with ... other study procedures",
"criterion": "compliance with other study procedures",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Willingness and ability to comply with scheduled visits",
"criterion": "compliance with scheduled visits",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1,",
"criterions": [
{
"exact_snippets": "Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1",
"criterion": "radiological progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "after two cycles of \"Second PRRT\""
}
},
{
"exact_snippets": "Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1",
"criterion": "radiological progression",
"requirement": {
"requirement_type": "assessment method",
"expected_value": "RECIST version 1.1"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1",
"criterion": "radiological progression",
"requirement": {
"requirement_type": "timing",
"expected_value": "after two cycles of \"Second PRRT\""
}
},
{
"exact_snippets": "Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1",
"criterion": "radiological progression",
"requirement": {
"requirement_type": "assessment method",
"expected_value": "RECIST version 1.1"
}
}
]
}
},
{
"identified_line": {
"line": "* Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,",
"criterions": [
{
"exact_snippets": "Grade 4 hematotoxicity",
"criterion": "hematotoxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 4"
}
},
{
"exact_snippets": "Grade 4 ... nephrotoxicity",
"criterion": "nephrotoxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 4"
}
},
{
"exact_snippets": "unresolved AEs categorized as Grade 2 or higher",
"criterion": "adverse events",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "Grade"
}
]
}
}
},
{
"exact_snippets": "excluding alopecia and peripheral neuropathy",
"criterion": "adverse events",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"alopecia",
"peripheral neuropathy"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Grade 4 hematotoxicity",
"criterion": "hematotoxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 4"
}
},
{
"exact_snippets": "Grade 4 ... nephrotoxicity",
"criterion": "nephrotoxicity",
"requirement": {
"requirement_type": "severity",
"expected_value": "Grade 4"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unresolved AEs categorized as Grade 2 or higher",
"criterion": "adverse events",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "Grade"
}
]
}
}
},
{
"not_criteria": {
"exact_snippets": "excluding alopecia and peripheral neuropathy",
"criterion": "adverse events",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"alopecia",
"peripheral neuropathy"
]
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Pancreatic NET,",
"criterions": [
{
"exact_snippets": "Pancreatic NET",
"criterion": "Pancreatic NET",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pancreatic NET",
"criterion": "Pancreatic NET",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* NeuroEndocrine Carcinoma,",
"criterions": [
{
"exact_snippets": "NeuroEndocrine Carcinoma",
"criterion": "NeuroEndocrine Carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "NeuroEndocrine Carcinoma",
"criterion": "NeuroEndocrine Carcinoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Prior external beam radiation therapy to more than 25% of the bone marrow,",
"criterions": [
{
"exact_snippets": "Prior external beam radiation therapy to more than 25% of the bone marrow",
"criterion": "external beam radiation therapy to bone marrow",
"requirement": {
"requirement_type": "extent",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior external beam radiation therapy to more than 25% of the bone marrow",
"criterion": "external beam radiation therapy to bone marrow",
"requirement": {
"requirement_type": "extent",
"expected_value": {
"operator": ">",
"value": 25,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN or ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN),",
"criterions": [
{
"exact_snippets": "Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min",
"criterion": "renal function",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min",
"criterion": "renal function",
"requirement": {
"requirement_type": "GFR",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "mL/min"
}
}
},
{
"exact_snippets": "nephrotic syndrome",
"criterion": "nephrotic syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "severity",
"expected_value": "insufficiency"
}
},
{
"exact_snippets": "hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "ALT/AST",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "ALT/AST",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "total serum bilirubin > 2.5 x ULN",
"criterion": "total serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min",
"criterion": "renal function",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) < 40 mL/min",
"criterion": "renal function",
"requirement": {
"requirement_type": "GFR",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "mL/min"
}
}
}
]
},
{
"exact_snippets": "nephrotic syndrome",
"criterion": "nephrotic syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "severity",
"expected_value": "insufficiency"
}
},
{
"exact_snippets": "hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2.5 x ULN",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "ALT/AST",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "ALT/AST",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "x ULN"
}
}
}
]
},
{
"exact_snippets": "total serum bilirubin > 2.5 x ULN",
"criterion": "total serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2.5,
"unit": "x ULN"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range,",
"criterions": [
{
"exact_snippets": "Serum albumin < 3.0 g/dL",
"criterion": "serum albumin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 3.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "prothrombin time is within the normal range",
"criterion": "prothrombin time",
"requirement": {
"requirement_type": "range",
"expected_value": "within the normal range"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Serum albumin < 3.0 g/dL",
"criterion": "serum albumin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 3.0,
"unit": "g/dL"
}
}
},
"then_criteria": {
"not_criteria": {
"exact_snippets": "prothrombin time is within the normal range",
"criterion": "prothrombin time",
"requirement": {
"requirement_type": "range",
"expected_value": "within the normal range"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,",
"criterions": [
{
"exact_snippets": "Uncontrolled diabetes mellitus",
"criterion": "diabetes mellitus",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "fasting blood glucose above 2 ULN",
"criterion": "fasting blood glucose",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Uncontrolled diabetes mellitus",
"criterion": "diabetes mellitus",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "fasting blood glucose above 2 ULN",
"criterion": "fasting blood glucose",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,",
"criterions": [
{
"exact_snippets": "Uncontrolled decompensated heart failure",
"criterion": "decompensated heart failure",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "myocardial infarction uncontrolled",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "stroke ... during the last 12 months",
"criterion": "stroke",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "pulmonary embolism ... during the last 12 months",
"criterion": "pulmonary embolism",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "revascularization procedure ... during the last 12 months",
"criterion": "revascularization procedure",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
},
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "uncontrolled cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "clinically significant bradycardia ... during the last 12 months",
"criterion": "bradycardia",
"requirement": {
"requirement_type": "clinical significance",
"expected_value": true
}
},
{
"exact_snippets": "clinically significant bradycardia ... during the last 12 months",
"criterion": "bradycardia",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrolled decompensated heart failure",
"criterion": "decompensated heart failure",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "myocardial infarction uncontrolled",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "stroke ... during the last 12 months",
"criterion": "stroke",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "pulmonary embolism ... during the last 12 months",
"criterion": "pulmonary embolism",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "revascularization procedure ... during the last 12 months",
"criterion": "revascularization procedure",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "uncontrolled cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "clinically significant bradycardia ... during the last 12 months",
"criterion": "bradycardia",
"requirement": {
"requirement_type": "clinical significance",
"expected_value": true
}
},
{
"exact_snippets": "clinically significant bradycardia ... during the last 12 months",
"criterion": "bradycardia",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 12,
"unit": "months"
}
]
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)",
"criterions": [
{
"exact_snippets": "Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 160,
"unit": "mmHg"
},
{
"operator": ">=",
"value": 95,
"unit": "mmHg"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 160,
"unit": "mmHg"
},
{
"operator": ">=",
"value": 95,
"unit": "mmHg"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),",
"criterions": [
{
"exact_snippets": "Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment and stabilization duration",
"expected_value": {
"operator": ">=",
"value": 24,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease",
"criterion": "history of brain metastases",
"requirement": {
"requirement_type": "imaging requirement",
"expected_value": [
"head CT scan with contrast",
"MRI"
]
}
},
{
"exact_snippets": "Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease",
"criterion": "history of brain metastases",
"requirement": {
"requirement_type": "disease status",
"expected_value": "stable"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment and stabilization duration",
"expected_value": {
"operator": ">=",
"value": 24,
"unit": "weeks"
}
}
},
{
"and_criteria": [
{
"exact_snippets": "Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease",
"criterion": "history of brain metastases",
"requirement": {
"requirement_type": "imaging requirement",
"expected_value": [
"head CT scan with contrast",
"MRI"
]
}
},
{
"exact_snippets": "Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease",
"criterion": "history of brain metastases",
"requirement": {
"requirement_type": "disease status",
"expected_value": "stable"
}
}
]
}
]
}
},
{
"not_criteria": {
"exact_snippets": "Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "treatment and stabilization duration",
"expected_value": {
"operator": ">=",
"value": 24,
"unit": "weeks"
}
}
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnancy or breast feeding,",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast feeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast feeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results,",
"criterions": [
{
"exact_snippets": "Substance abuse ... may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "substance abuse",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
},
{
"exact_snippets": "medical ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "medical conditions",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
},
{
"exact_snippets": "psychological ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "psychological conditions",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
},
{
"exact_snippets": "social conditions that may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "social conditions",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Substance abuse ... may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "substance abuse",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
},
{
"exact_snippets": "medical ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "medical conditions",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
},
{
"exact_snippets": "psychological ... conditions that may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "psychological conditions",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
},
{
"exact_snippets": "social conditions that may interfere with the patient's participation in the study or evaluation of the study results",
"criterion": "social conditions",
"requirement": {
"requirement_type": "interference with study participation or evaluation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,",
"criterions": [
{
"exact_snippets": "Known hypersensitivity to any of the study drugs",
"criterion": "hypersensitivity to study drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "hypersensitivity to ... study drug classes",
"criterion": "hypersensitivity to study drug classes",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "hypersensitivity to ... any constituent of the products",
"criterion": "hypersensitivity to constituents of the products",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Known hypersensitivity to any of the study drugs",
"criterion": "hypersensitivity to study drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "hypersensitivity to ... study drug classes",
"criterion": "hypersensitivity to study drug classes",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "hypersensitivity to ... any constituent of the products",
"criterion": "hypersensitivity to constituents of the products",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Concomitant participation or participation within the last 30 days in another clinical trial,",
"criterions": [
{
"exact_snippets": "Concomitant participation ... in another clinical trial",
"criterion": "concomitant participation in another clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "participation within the last 30 days in another clinical trial",
"criterion": "participation in another clinical trial within the last 30 days",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Concomitant participation ... in another clinical trial",
"criterion": "concomitant participation in another clinical trial",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "participation within the last 30 days in another clinical trial",
"criterion": "participation in another clinical trial within the last 30 days",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.",
"criterions": [
{
"exact_snippets": "History of other solid tumor in 5 years before the inclusion",
"criterion": "history of other solid tumor",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "excepted of cancer in situ of the cervix",
"criterion": "cancer in situ of the cervix",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "excepted of ... skin cancer (basal or squamous cell) treated and controlled",
"criterion": "skin cancer (basal or squamous cell)",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "excepted of ... skin cancer (basal or squamous cell) treated and controlled",
"criterion": "skin cancer (basal or squamous cell)",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "treated and controlled"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "History of other solid tumor in 5 years before the inclusion",
"criterion": "history of other solid tumor",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
},
{
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "excepted of cancer in situ of the cervix",
"criterion": "cancer in situ of the cervix",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "excepted of ... skin cancer (basal or squamous cell) treated and controlled",
"criterion": "skin cancer (basal or squamous cell)",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "excepted of ... skin cancer (basal or squamous cell) treated and controlled",
"criterion": "skin cancer (basal or squamous cell)",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "treated and controlled"
}
}
]
}
]
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.",
"criterions": [
{
"exact_snippets": "Legal incapacity",
"criterion": "legal capacity",
"requirement": {
"requirement_type": "status",
"expected_value": "incapacity"
}
},
{
"exact_snippets": "physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study",
"criterion": "physical, psychological or mental status",
"requirement": {
"requirement_type": "interference with ability",
"expected_value": "sign informed consent or terminate the study"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Legal incapacity",
"criterion": "legal capacity",
"requirement": {
"requirement_type": "status",
"expected_value": "incapacity"
}
},
{
"exact_snippets": "physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study",
"criterion": "physical, psychological or mental status",
"requirement": {
"requirement_type": "interference with ability",
"expected_value": "sign informed consent or terminate the study"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Disease control after \"First PRRT\" ≥ 12 months,",
"criterions": [
{
"exact_snippets": "Disease control after \"First PRRT\" ≥ 12 months",
"criterion": "disease control duration after First PRRT",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Disease control after \"First PRRT\" 12 months",
"criterion": "disease control duration after First PRRT",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,",
"criterions": [
{
"exact_snippets": "progression of disease (clinic, biologic and/or radiologic)",
"criterion": "progression of disease",
"requirement": {
"requirement_type": "type",
"expected_value": [
"clinic",
"biologic",
"radiologic"
]
}
},
{
"exact_snippets": "after a first PRRT",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "PRRT"
}
},
{
"exact_snippets": "after a first PRRT",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment count",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "treatment"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "progression of disease (clinic, biologic and/or radiologic)",
"criterion": "progression of disease",
"requirement": {
"requirement_type": "type",
"expected_value": "clinic"
}
},
{
"exact_snippets": "progression of disease (clinic, biologic and/or radiologic)",
"criterion": "progression of disease",
"requirement": {
"requirement_type": "type",
"expected_value": "biologic"
}
},
{
"exact_snippets": "progression of disease (clinic, biologic and/or radiologic)",
"criterion": "progression of disease",
"requirement": {
"requirement_type": "type",
"expected_value": "radiologic"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "after a first PRRT",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment type",
"expected_value": "PRRT"
}
},
{
"exact_snippets": "after a first PRRT",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "treatment count",
"expected_value": {
"operator": "=",
"value": 1,
"unit": "treatment"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Decision of retreatment with Lutathera® (defined as \"Second PRRT\") validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,",
"criterions": [
{
"exact_snippets": "Decision of retreatment with Lutathera® ... validated by RENATEN and/or multidisciplinary tumor board",
"criterion": "retreatment with Lutathera®",
"requirement": {
"requirement_type": "validation",
"expected_value": [
"RENATEN",
"multidisciplinary tumor board"
]
}
},
{
"exact_snippets": "Decision of retreatment with Lutathera® ... in the scope of the French reimbursement process",
"criterion": "retreatment with Lutathera®",
"requirement": {
"requirement_type": "scope",
"expected_value": "French reimbursement process"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Decision of retreatment with Lutathera® ... validated by RENATEN and/or multidisciplinary tumor board",
"criterion": "retreatment with Lutathera®",
"requirement": {
"requirement_type": "validation",
"expected_value": "RENATEN"
}
},
{
"exact_snippets": "Decision of retreatment with Lutathera® ... validated by RENATEN and/or multidisciplinary tumor board",
"criterion": "retreatment with Lutathera®",
"requirement": {
"requirement_type": "validation",
"expected_value": "multidisciplinary tumor board"
}
}
]
},
{
"exact_snippets": "Decision of retreatment with Lutathera® ... in the scope of the French reimbursement process",
"criterion": "retreatment with Lutathera®",
"requirement": {
"requirement_type": "scope",
"expected_value": "French reimbursement process"
}
}
]
}
},
{
"identified_line": {
"line": "* Affiliation to the French Social Security System",
"criterions": [
{
"exact_snippets": "Affiliation to the French Social Security System",
"criterion": "affiliation to the French Social Security System",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Patient who did not respond (no CR, PR or SD) to \"first PRRT\".",
"criterions": [
{
"exact_snippets": "Patient who did not respond (no CR, PR or SD) to \"first PRRT\".",
"criterion": "response to first PRRT",
"requirement": {
"requirement_type": "response",
"expected_value": [
"CR",
"PR",
"SD"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}