{
"info": {
"nct_id": "NCT00920920",
"official_title": "A International Study on MRI-guided Brachytherapy in Locally Advanced Cervical Cancer",
"inclusion_criteria": "* Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT\n* Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.\n* Staging according to FIGO and TNM guidelines\n* MRI of pelvis at diagnosis is performed\n* MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed\n* MRI with the applicator in place at the time of (first) BT will be performed\n* Para-aortic metastatic nodes below L1-L2 are allowed\n* Patient informed consent\nHealthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin\n* Metastatic disease beyond para-aortic region (L1-L2)\n* Previous pelvic or abdominal radiotherapy\n* Previous total or partial hysterectomy\n* Combination of preoperative radiotherapy with surgery\n* Patients receiving BT only\n* Patients receiving EBRT only\n* Patients receiving neoadjuvant chemotherapy\n* Contra indications to MRI\n* Contra indications to BT\n* Active infection or severe medical condition endangering treatment delivery\n* Pregnant, lactating or childbearing potential without adequate contraception",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT",
"criterions": [
{
"exact_snippets": "Cancer of the uterine cervix",
"criterion": "cancer type",
"requirement": {
"requirement_type": "specificity",
"expected_value": "uterine cervix"
}
},
{
"exact_snippets": "considered suitable for curative treatment",
"criterion": "treatment suitability",
"requirement": {
"requirement_type": "suitability",
"expected_value": "curative treatment"
}
},
{
"exact_snippets": "definitive radio-(chemo)therapy",
"criterion": "treatment type",
"requirement": {
"requirement_type": "specificity",
"expected_value": [
"radiotherapy",
"chemotherapy"
]
}
},
{
"exact_snippets": "including MRI guided BT",
"criterion": "treatment guidance",
"requirement": {
"requirement_type": "guidance",
"expected_value": "MRI guided BT"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cancer of the uterine cervix",
"criterion": "cancer type",
"requirement": {
"requirement_type": "specificity",
"expected_value": "uterine cervix"
}
},
{
"exact_snippets": "considered suitable for curative treatment",
"criterion": "treatment suitability",
"requirement": {
"requirement_type": "suitability",
"expected_value": "curative treatment"
}
},
{
"exact_snippets": "definitive radio-(chemo)therapy",
"criterion": "treatment type",
"requirement": {
"requirement_type": "specificity",
"expected_value": [
"radiotherapy",
"chemotherapy"
]
}
},
{
"exact_snippets": "including MRI guided BT",
"criterion": "treatment guidance",
"requirement": {
"requirement_type": "guidance",
"expected_value": "MRI guided BT"
}
}
]
}
},
{
"identified_line": {
"line": "* Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.",
"criterions": [
{
"exact_snippets": "Positive biopsy showing squamous-cell carcinoma",
"criterion": "squamous-cell carcinoma of the uterine cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Positive biopsy showing ... adenocarcinoma",
"criterion": "adenocarcinoma of the uterine cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Positive biopsy showing ... adeno-squamous cell carcinoma",
"criterion": "adeno-squamous cell carcinoma of the uterine cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Positive biopsy showing squamous-cell carcinoma",
"criterion": "squamous-cell carcinoma of the uterine cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Positive biopsy showing ... adenocarcinoma",
"criterion": "adenocarcinoma of the uterine cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Positive biopsy showing ... adeno-squamous cell carcinoma",
"criterion": "adeno-squamous cell carcinoma of the uterine cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Staging according to FIGO and TNM guidelines",
"criterions": [
{
"exact_snippets": "Staging according to FIGO",
"criterion": "staging",
"requirement": {
"requirement_type": "guideline",
"expected_value": "FIGO"
}
},
{
"exact_snippets": "Staging according to ... TNM guidelines",
"criterion": "staging",
"requirement": {
"requirement_type": "guideline",
"expected_value": "TNM"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Staging according to FIGO",
"criterion": "staging",
"requirement": {
"requirement_type": "guideline",
"expected_value": "FIGO"
}
},
{
"exact_snippets": "Staging according to ... TNM guidelines",
"criterion": "staging",
"requirement": {
"requirement_type": "guideline",
"expected_value": "TNM"
}
}
]
}
},
{
"identified_line": {
"line": "* MRI of pelvis at diagnosis is performed",
"criterions": [
{
"exact_snippets": "MRI of pelvis at diagnosis is performed",
"criterion": "MRI of pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "MRI of pelvis at diagnosis is performed",
"criterion": "MRI of pelvis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* MRI with the applicator in place at the time of (first) BT will be performed",
"criterions": [
{
"exact_snippets": "MRI with the applicator in place",
"criterion": "MRI with applicator",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at the time of (first) BT",
"criterion": "timing of MRI",
"requirement": {
"requirement_type": "timing",
"expected_value": "at the time of (first) BT"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "MRI with the applicator in place",
"criterion": "MRI with applicator",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at the time of (first) BT",
"criterion": "timing of MRI",
"requirement": {
"requirement_type": "timing",
"expected_value": "at the time of (first) BT"
}
}
]
}
},
{
"identified_line": {
"line": "* Para-aortic metastatic nodes below L1-L2 are allowed",
"criterions": [
{
"exact_snippets": "Para-aortic metastatic nodes below L1-L2 are allowed",
"criterion": "para-aortic metastatic nodes",
"requirement": {
"requirement_type": "location",
"expected_value": "below L1-L2"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Para-aortic metastatic nodes below L1-L2 are allowed",
"criterion": "para-aortic metastatic nodes",
"requirement": {
"requirement_type": "location",
"expected_value": "below L1-L2"
}
}
]
}
},
{
"identified_line": {
"line": "* Patient informed consent",
"criterions": [
{
"exact_snippets": "Patient informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"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": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"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"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin",
"criterions": [
{
"exact_snippets": "Other primary malignancies",
"criterion": "primary malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "except carcinoma in situ of the cervix",
"criterion": "carcinoma in situ of the cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "except ... basal cell carcinoma of the skin",
"criterion": "basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Other primary malignancies",
"criterion": "primary malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"not_criteria": {
"exact_snippets": "except carcinoma in situ of the cervix",
"criterion": "carcinoma in situ of the cervix",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
},
{
"not_criteria": {
"exact_snippets": "except ... basal cell carcinoma of the skin",
"criterion": "basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Metastatic disease beyond para-aortic region (L1-L2)",
"criterions": [
{
"exact_snippets": "Metastatic disease beyond para-aortic region (L1-L2)",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "location",
"expected_value": "beyond para-aortic region (L1-L2)"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Metastatic disease beyond para-aortic region (L1-L2)",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "location",
"expected_value": "beyond para-aortic region (L1-L2)"
}
}
}
},
{
"identified_line": {
"line": "* Previous pelvic or abdominal radiotherapy",
"criterions": [
{
"exact_snippets": "Previous pelvic or abdominal radiotherapy",
"criterion": "pelvic or abdominal radiotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous pelvic or abdominal radiotherapy",
"criterion": "pelvic or abdominal radiotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterions": [
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "imaging type",
"expected_value": [
"MRI",
"CT",
"PET-CT"
]
}
},
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "timing",
"expected_value": "at diagnosis"
}
},
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "status",
"expected_value": "performed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "MRI"
}
},
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "CT"
}
},
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "imaging type",
"expected_value": "PET-CT"
}
}
]
},
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "timing",
"expected_value": "at diagnosis"
}
},
{
"exact_snippets": "MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed",
"criterion": "imaging of retroperitoneal space and abdomen",
"requirement": {
"requirement_type": "status",
"expected_value": "performed"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Previous total or partial hysterectomy",
"criterions": [
{
"exact_snippets": "Previous total or partial hysterectomy",
"criterion": "hysterectomy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"total",
"partial"
]
}
},
{
"exact_snippets": "Previous total or partial hysterectomy",
"criterion": "hysterectomy",
"requirement": {
"requirement_type": "temporal",
"expected_value": "previous"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Combination of preoperative radiotherapy with surgery",
"criterions": [
{
"exact_snippets": "preoperative radiotherapy",
"criterion": "preoperative radiotherapy",
"requirement": {
"requirement_type": "combination with surgery",
"expected_value": true
}
},
{
"exact_snippets": "surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "combination with preoperative radiotherapy",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients receiving BT only",
"criterions": [
{
"exact_snippets": "Patients receiving BT only",
"criterion": "treatment type",
"requirement": {
"requirement_type": "specific treatment",
"expected_value": "BT only"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients receiving EBRT only",
"criterions": [
{
"exact_snippets": "Patients receiving EBRT only",
"criterion": "EBRT",
"requirement": {
"requirement_type": "treatment",
"expected_value": "only"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients receiving neoadjuvant chemotherapy",
"criterions": [
{
"exact_snippets": "Patients receiving neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "receiving"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Contra indications to MRI",
"criterions": [
{
"exact_snippets": "Contra indications to MRI",
"criterion": "MRI contraindications",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Contra indications to BT",
"criterions": [
{
"exact_snippets": "Contra indications to BT",
"criterion": "contraindications to BT",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Active infection or severe medical condition endangering treatment delivery",
"criterions": [
{
"exact_snippets": "Active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe medical condition",
"criterion": "medical condition",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pregnant, lactating or childbearing potential without adequate contraception",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "without adequate contraception",
"criterion": "adequate contraception",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}