{
"info": {
"nct_id": "NCT01379482",
"official_title": "Phase II Study of Patients With Peritoneal Carcinomatosis From Gastric Cancer Treated With Preoperative Systemic Chemotherapy Followed by Peritonectomy and Intraperitoneal Chemotherapy",
"inclusion_criteria": "* Histologically confirmed diagnosis of primary gastric cancer + histologically and/or radiologically confirmed peritoneal carcinomatosis diagnosis\n* Adequate renal-, hematopoietic- and liver functions\n* WHO performance status (WHO) of < 2.\nHealthy volunteers allowed\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Distant metastases\n* Surgically not resectable lymph-node metastasis\n* Contraindication to chemotherapy treatment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Adequate renal-, hematopoietic- and liver functions",
"criterions": [
{
"exact_snippets": "Adequate renal-",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hematopoietic-",
"criterion": "hematopoietic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... liver functions",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate renal-",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hematopoietic-",
"criterion": "hematopoietic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... liver functions",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* WHO performance status (WHO) of < 2.",
"criterions": [
{
"exact_snippets": "WHO performance status (WHO) of < 2",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "WHO performance status (WHO) of < 2",
"criterion": "WHO performance status",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"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 maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Distant metastases",
"criterions": [
{
"exact_snippets": "Distant metastases",
"criterion": "distant metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Distant metastases",
"criterion": "distant metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Surgically not resectable lymph-node metastasis",
"criterions": [
{
"exact_snippets": "Surgically not resectable lymph-node metastasis",
"criterion": "lymph-node metastasis",
"requirement": {
"requirement_type": "resectability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgically not resectable lymph-node metastasis",
"criterion": "lymph-node metastasis",
"requirement": {
"requirement_type": "resectability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Contraindication to chemotherapy treatment",
"criterions": [
{
"exact_snippets": "Contraindication to chemotherapy treatment",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Contraindication to chemotherapy treatment",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histologically confirmed diagnosis of primary gastric cancer + histologically and/or radiologically confirmed peritoneal carcinomatosis diagnosis",
"criterions": [
{
"exact_snippets": "Histologically confirmed diagnosis of primary gastric cancer",
"criterion": "primary gastric cancer",
"requirement": {
"requirement_type": "diagnosis confirmation method",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "histologically and/or radiologically confirmed peritoneal carcinomatosis diagnosis",
"criterion": "peritoneal carcinomatosis",
"requirement": {
"requirement_type": "diagnosis confirmation method",
"expected_value": [
"histologically confirmed",
"radiologically confirmed"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed diagnosis of primary gastric cancer",
"criterion": "primary gastric cancer",
"requirement": {
"requirement_type": "diagnosis confirmation method",
"expected_value": "histologically confirmed"
}
},
{
"or_criteria": [
{
"exact_snippets": "histologically and/or radiologically confirmed peritoneal carcinomatosis diagnosis",
"criterion": "peritoneal carcinomatosis",
"requirement": {
"requirement_type": "diagnosis confirmation method",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "histologically and/or radiologically confirmed peritoneal carcinomatosis diagnosis",
"criterion": "peritoneal carcinomatosis",
"requirement": {
"requirement_type": "diagnosis confirmation method",
"expected_value": "radiologically confirmed"
}
}
]
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}