{
"info": {
"nct_id": "NCT04680260",
"official_title": "OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach",
"inclusion_criteria": "* Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)\n* No evidence of further disease based on pre-treatment work-up according to SOC\n* Age at least 18 years\n* Eastern Cooperative Oncology Group performance status 0-2\n* Clinically eligible for adjuvant triple CT at investigators decision.\n* Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)\n* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable\n* Written and verbally informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis\n* Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy\n* Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1\n* Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri\n* Pregnant (positive pregnancy test) or breast feeding women\n* Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)",
"criterions": [
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by resection",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"resection"
]
}
},
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... radiofrequency ablation",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"radiofrequency ablation"
]
}
},
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... stereotactic body radiation therapy",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"stereotactic body radiation therapy"
]
}
},
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... other experimental local treatment options",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"other experimental local treatment options"
]
}
},
{
"exact_snippets": "not including cytoreductive surgery (CRS)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"cytoreductive surgery (CRS)"
]
}
},
{
"exact_snippets": "not including ... hyperthermic intra-peritoneal chemotherapy (HIPEC)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hyperthermic intra-peritoneal chemotherapy (HIPEC)"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by resection",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"resection"
]
}
},
{
"not_criteria": {
"exact_snippets": "not including cytoreductive surgery (CRS)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"cytoreductive surgery (CRS)"
]
}
}
},
{
"not_criteria": {
"exact_snippets": "not including ... hyperthermic intra-peritoneal chemotherapy (HIPEC)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hyperthermic intra-peritoneal chemotherapy (HIPEC)"
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... radiofrequency ablation",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"radiofrequency ablation"
]
}
},
{
"not_criteria": {
"exact_snippets": "not including cytoreductive surgery (CRS)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"cytoreductive surgery (CRS)"
]
}
}
},
{
"not_criteria": {
"exact_snippets": "not including ... hyperthermic intra-peritoneal chemotherapy (HIPEC)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hyperthermic intra-peritoneal chemotherapy (HIPEC)"
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... stereotactic body radiation therapy",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"stereotactic body radiation therapy"
]
}
},
{
"not_criteria": {
"exact_snippets": "not including cytoreductive surgery (CRS)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"cytoreductive surgery (CRS)"
]
}
}
},
{
"not_criteria": {
"exact_snippets": "not including ... hyperthermic intra-peritoneal chemotherapy (HIPEC)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hyperthermic intra-peritoneal chemotherapy (HIPEC)"
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Radical intended treatment for metastatic spread from CRC, by ... other experimental local treatment options",
"criterion": "treatment for metastatic spread from CRC",
"requirement": {
"requirement_type": "type",
"expected_value": [
"other experimental local treatment options"
]
}
},
{
"not_criteria": {
"exact_snippets": "not including cytoreductive surgery (CRS)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"cytoreductive surgery (CRS)"
]
}
}
},
{
"not_criteria": {
"exact_snippets": "not including ... hyperthermic intra-peritoneal chemotherapy (HIPEC)",
"criterion": "treatment exclusion",
"requirement": {
"requirement_type": "type",
"expected_value": [
"hyperthermic intra-peritoneal chemotherapy (HIPEC)"
]
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* No evidence of further disease based on pre-treatment work-up according to SOC",
"criterions": [
{
"exact_snippets": "No evidence of further disease",
"criterion": "further disease",
"requirement": {
"requirement_type": "evidence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No evidence of further disease",
"criterion": "further disease",
"requirement": {
"requirement_type": "evidence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Age at least 18 years",
"criterions": [
{
"exact_snippets": "Age at least 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age at least 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group performance status 0-2",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group performance status 0-2",
"criterion": "Eastern Cooperative Oncology Group 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": "Eastern Cooperative Oncology Group performance status 0-2",
"criterion": "Eastern Cooperative Oncology Group performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Clinically eligible for adjuvant triple CT at investigators decision.",
"criterions": [
{
"exact_snippets": "Clinically eligible for adjuvant triple CT",
"criterion": "adjuvant triple CT eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
},
{
"exact_snippets": "at investigators decision",
"criterion": "investigator's decision",
"requirement": {
"requirement_type": "decision",
"expected_value": "investigator's discretion"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Clinically eligible for adjuvant triple CT",
"criterion": "adjuvant triple CT eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
},
{
"exact_snippets": "at investigators decision",
"criterion": "investigator's decision",
"requirement": {
"requirement_type": "decision",
"expected_value": "investigator's discretion"
}
}
]
}
},
{
"identified_line": {
"line": "* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable",
"criterions": [
{
"exact_snippets": "Anticonception for fertile women",
"criterion": "anticonception for fertile women",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Anticonception ... for male patients with a fertile partner",
"criterion": "anticonception for male patients with a fertile partner",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable",
"criterion": "acceptable anticonception methods",
"requirement": {
"requirement_type": "methods",
"expected_value": [
"Intrauterine device",
"vasectomy of a female subject's male partner",
"hormonal contraceptive"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Anticonception for fertile women",
"criterion": "anticonception for fertile women",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable",
"criterion": "acceptable anticonception methods",
"requirement": {
"requirement_type": "methods",
"expected_value": [
"Intrauterine device",
"vasectomy of a female subject's male partner",
"hormonal contraceptive"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Anticonception ... for male patients with a fertile partner",
"criterion": "anticonception for male patients with a fertile partner",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable",
"criterion": "acceptable anticonception methods",
"requirement": {
"requirement_type": "methods",
"expected_value": [
"Intrauterine device",
"vasectomy of a female subject's male partner",
"hormonal contraceptive"
]
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Written and verbally informed consent",
"criterions": [
{
"exact_snippets": "Written and verbally informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "type",
"expected_value": [
"written",
"verbal"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Written and verbally informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "type",
"expected_value": [
"written",
"verbal"
]
}
}
]
}
},
{
"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 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": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)",
"criterions": [
{
"exact_snippets": "Adequate bone marrow ... Absolute neutrophil count ≥1.5x109/l",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x10^9/l"
}
}
},
{
"exact_snippets": "Adequate bone marrow ... thrombocytes ≥ 100x109/l",
"criterion": "thrombocytes",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x10^9/l"
}
}
},
{
"exact_snippets": "Adequate ... liver function ... Bilirubin ≤ 1.5 x upper normal value",
"criterion": "bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x upper normal value"
}
}
},
{
"exact_snippets": "Adequate ... liver function ... alanine aminotransferase ≤ 3 x upper normal value",
"criterion": "alanine aminotransferase",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x upper normal value"
}
}
},
{
"exact_snippets": "Adequate ... renal function ... calculated or measured renal glomerular filtration rate at least 30 mL/min",
"criterion": "renal glomerular filtration rate",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "mL/min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate bone marrow ... Absolute neutrophil count ≥1.5x109/l",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "x10^9/l"
}
}
},
{
"exact_snippets": "Adequate bone marrow ... thrombocytes ≥ 100x109/l",
"criterion": "thrombocytes",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "x10^9/l"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Adequate ... liver function ... Bilirubin ≤ 1.5 x upper normal value",
"criterion": "bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x upper normal value"
}
}
},
{
"exact_snippets": "Adequate ... liver function ... alanine aminotransferase ≤ 3 x upper normal value",
"criterion": "alanine aminotransferase",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x upper normal value"
}
}
}
]
}
]
},
{
"exact_snippets": "Adequate ... renal function ... calculated or measured renal glomerular filtration rate at least 30 mL/min",
"criterion": "renal glomerular filtration rate",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "mL/min"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis",
"criterions": [
{
"exact_snippets": "Radiological evidence of distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "evidence",
"expected_value": "radiological"
}
},
{
"exact_snippets": "CT- chest, abdomen, and pelvis",
"criterion": "CT scan",
"requirement": {
"requirement_type": "locations",
"expected_value": [
"chest",
"abdomen",
"pelvis"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Radiological evidence of distant metastasis",
"criterion": "distant metastasis",
"requirement": {
"requirement_type": "evidence",
"expected_value": "radiological"
}
},
{
"exact_snippets": "CT- chest, abdomen, and pelvis",
"criterion": "CT scan",
"requirement": {
"requirement_type": "locations",
"expected_value": [
"chest",
"abdomen",
"pelvis"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1",
"criterions": [
{
"exact_snippets": "Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1",
"criterion": "neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "NCI-CTCAE grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1",
"criterion": "neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "NCI-CTCAE grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri",
"criterions": [
{
"exact_snippets": "Other malignant tumor within 5 years",
"criterion": "other malignant tumor",
"requirement": {
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
},
{
"exact_snippets": "except non-melanoma skin cancer",
"criterion": "non-melanoma skin cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "except ... carcinoma in situ cervicis uteri",
"criterion": "carcinoma in situ cervicis uteri",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Other malignant tumor within 5 years",
"criterion": "other malignant tumor",
"requirement": {
"requirement_type": "time since diagnosis",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
},
{
"not_criteria": {
"exact_snippets": "except non-melanoma skin cancer",
"criterion": "non-melanoma skin cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "except ... carcinoma in situ cervicis uteri",
"criterion": "carcinoma in situ cervicis uteri",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Pregnant (positive pregnancy test) or breast feeding women",
"criterions": [
{
"exact_snippets": "Pregnant (positive pregnancy test)",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "breast feeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant (positive pregnancy test)",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "breast feeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine",
"criterions": [
{
"exact_snippets": "Intolerance or allergy to 5FU",
"criterion": "5FU",
"requirement": {
"requirement_type": "intolerance",
"expected_value": true
}
},
{
"exact_snippets": "Intolerance or allergy to 5FU",
"criterion": "5FU",
"requirement": {
"requirement_type": "allergy",
"expected_value": true
}
},
{
"exact_snippets": "Intolerance or allergy to ... leucovorin",
"criterion": "leucovorin",
"requirement": {
"requirement_type": "intolerance",
"expected_value": true
}
},
{
"exact_snippets": "Intolerance or allergy to ... leucovorin",
"criterion": "leucovorin",
"requirement": {
"requirement_type": "allergy",
"expected_value": true
}
},
{
"exact_snippets": "Intolerance or allergy to ... oxaliplatin",
"criterion": "oxaliplatin",
"requirement": {
"requirement_type": "intolerance",
"expected_value": true
}
},
{
"exact_snippets": "Intolerance or allergy to ... oxaliplatin",
"criterion": "oxaliplatin",
"requirement": {
"requirement_type": "allergy",
"expected_value": true
}
},
{
"exact_snippets": "Intolerance or allergy to ... irinotecan",
"criterion": "irinotecan",
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