{
"info": {
"nct_id": "NCT04397601",
"official_title": "AflibeRcept or Bevacizumab In Combination With Folfiri as Second-line Treatment of RAS Mutated metastaTIc cOlorectal Cancer patieNts",
"inclusion_criteria": "* Cytological or histological diagnosis of RAS mutated mCRC;\n* progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab;\n* stage IV;\n* age <75 years;\n* ECOG Performance Status 0 or 1;\n* life expectancy> 3 months;\n* negative pregnancy test for all potentially childbearing women.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* presence of primary non-treated stenosing colorectal neoplasm;\n* active or uncontrolled infections or bleedings;\n* other concomitant uncontrolled diseases or blood laboratory values contraindicating the study drugs at clinician evaluation;\n* presence of brain metastases;\n* refusal or inability to provide informed consent;\n* impossibility to guarantee follow-up.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Cytological or histological diagnosis of RAS mutated mCRC;",
"criterions": [
{
"exact_snippets": "Cytological or histological diagnosis of RAS mutated mCRC",
"criterion": "RAS mutation in mCRC",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cytological or histological diagnosis of RAS mutated mCRC",
"criterion": "RAS mutation in mCRC",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab;",
"criterions": [
{
"exact_snippets": "progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab",
"criterion": "progression at first-line chemotherapy",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"fluoropyrimidines",
"oxaliplatin",
"bevacizumab"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab",
"criterion": "progression at first-line chemotherapy",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"fluoropyrimidines",
"oxaliplatin",
"bevacizumab"
]
}
}
]
}
},
{
"identified_line": {
"line": "* stage IV;",
"criterions": [
{
"exact_snippets": "stage IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "stage IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
}
]
}
},
{
"identified_line": {
"line": "* age <75 years;",
"criterions": [
{
"exact_snippets": "age <75 years",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": "<",
"value": 75,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "age <75 years",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": "<",
"value": 75,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* ECOG Performance Status 0 or 1;",
"criterions": [
{
"exact_snippets": "ECOG Performance Status 0 or 1",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG Performance Status 0 or 1",
"criterion": "ECOG Performance Status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"0",
"1"
]
}
}
]
}
},
{
"identified_line": {
"line": "* life expectancy> 3 months;",
"criterions": [
{
"exact_snippets": "life expectancy> 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "life expectancy> 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* negative pregnancy test for all potentially childbearing women.",
"criterions": [
{
"exact_snippets": "negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "potentially childbearing women",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "potentially childbearing women",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "status",
"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 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": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* presence of primary non-treated stenosing colorectal neoplasm;",
"criterions": [
{
"exact_snippets": "presence of primary non-treated stenosing colorectal neoplasm",
"criterion": "primary stenosing colorectal neoplasm",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of primary non-treated stenosing colorectal neoplasm",
"criterion": "primary stenosing colorectal neoplasm",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "non-treated"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "presence of primary non-treated stenosing colorectal neoplasm",
"criterion": "primary stenosing colorectal neoplasm",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of primary non-treated stenosing colorectal neoplasm",
"criterion": "primary stenosing colorectal neoplasm",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "non-treated"
}
}
]
}
},
{
"identified_line": {
"line": "* other concomitant uncontrolled diseases or blood laboratory values contraindicating the study drugs at clinician evaluation;",
"criterions": [
{
"exact_snippets": "other concomitant uncontrolled diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "blood laboratory values contraindicating the study drugs",
"criterion": "blood laboratory values",
"requirement": {
"requirement_type": "contraindication",
"expected_value": "study drugs"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "other concomitant uncontrolled diseases",
"criterion": "concomitant diseases",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "blood laboratory values contraindicating the study drugs",
"criterion": "blood laboratory values",
"requirement": {
"requirement_type": "contraindication",
"expected_value": "study drugs"
}
}
]
}
},
{
"identified_line": {
"line": "* presence of brain metastases;",
"criterions": [
{
"exact_snippets": "presence of brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "presence of brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* refusal or inability to provide informed consent;",
"criterions": [
{
"exact_snippets": "refusal or inability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability to provide",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "refusal or inability to provide informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability to provide",
"expected_value": true
}
}
]
}
}
},
{
"identified_line": {
"line": "* impossibility to guarantee follow-up.",
"criterions": [
{
"exact_snippets": "impossibility to guarantee follow-up",
"criterion": "follow-up",
"requirement": {
"requirement_type": "possibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "impossibility to guarantee follow-up",
"criterion": "follow-up",
"requirement": {
"requirement_type": "possibility",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* active or uncontrolled infections or bleedings;",
"criterions": [
{
"exact_snippets": "active or uncontrolled infections",
"criterion": "infections",
"requirement": {
"requirement_type": "status",
"expected_value": [
"active",
"uncontrolled"
]
}
},
{
"exact_snippets": "active or uncontrolled ... bleedings",
"criterion": "bleedings",
"requirement": {
"requirement_type": "status",
"expected_value": [
"active",
"uncontrolled"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "active or uncontrolled infections",
"criterion": "infections",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "active or uncontrolled infections",
"criterion": "infections",
"requirement": {
"requirement_type": "status",
"expected_value": "uncontrolled"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "active or uncontrolled ... bleedings",
"criterion": "bleedings",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "active or uncontrolled ... bleedings",
"criterion": "bleedings",
"requirement": {
"requirement_type": "status",
"expected_value": "uncontrolled"
}
}
]
}
]
}
}
],
"failed_miscellaneous": []
}