{
"info": {
"nct_id": "NCT01760694",
"official_title": "Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer",
"inclusion_criteria": "* Histologically proven Exocrine Adenocarcinoma of the pancreas\n* Clinically resectable or marginally resectable disease\n* No prior radiation or chemotherapy for carcinoma of the pancreas\n* ECOG performance status of 0-1\n* Patients must be medically able to undergo surgical resection\n* Patients of child bearing potential must follow study specific precautions\n* Women that are lactating will not be excluded on the condition that they dispose their breast milk.\n* Adequate hematologic and biochemical parameters.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior treatment for pancreatic cancer.\n* Concurrent investigational treatments.\n* Unresectable pancreatic mass.\n* Neuroendocrine Histological pancreatic cancer\n* Distant Metastatic disease\n* Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically proven Exocrine Adenocarcinoma of the pancreas",
"criterions": [
{
"exact_snippets": "Histologically proven Exocrine Adenocarcinoma of the pancreas",
"criterion": "Exocrine Adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
]
}
]
},
{
"line": "* Clinically resectable or marginally resectable disease",
"criterions": [
{
"exact_snippets": "Clinically resectable",
"criterion": "disease resectability",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": "clinically resectable"
}
]
},
{
"exact_snippets": "marginally resectable disease",
"criterion": "disease resectability",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": "marginally resectable"
}
]
}
]
},
{
"line": "* No prior radiation or chemotherapy for carcinoma of the pancreas",
"criterions": [
{
"exact_snippets": "No prior radiation ... carcinoma of the pancreas",
"criterion": "prior radiation for carcinoma of the pancreas",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... chemotherapy for carcinoma of the pancreas",
"criterion": "prior chemotherapy for carcinoma of the pancreas",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* ECOG performance status of 0-1",
"criterions": [
{
"exact_snippets": "ECOG performance status of 0-1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Patients must be medically able to undergo surgical resection",
"criterions": [
{
"exact_snippets": "medically able to undergo surgical resection",
"criterion": "ability to undergo surgical resection",
"requirements": [
{
"requirement_type": "medical ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients of child bearing potential must follow study specific precautions",
"criterions": [
{
"exact_snippets": "Patients of child bearing potential",
"criterion": "child bearing potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "must follow study specific precautions",
"criterion": "study specific precautions",
"requirements": [
{
"requirement_type": "adherence",
"expected_value": true
}
]
}
]
},
{
"line": "* Women that are lactating will not be excluded on the condition that they dispose their breast milk.",
"criterions": [
{
"exact_snippets": "Women that are lactating",
"criterion": "lactating",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "dispose their breast milk"
}
]
}
]
},
{
"line": "* Adequate hematologic and biochemical parameters.",
"criterions": [
{
"exact_snippets": "Adequate hematologic ... parameters.",
"criterion": "hematologic parameters",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... biochemical parameters.",
"criterion": "biochemical parameters",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior treatment for pancreatic cancer.",
"criterions": [
{
"exact_snippets": "Prior treatment for pancreatic cancer",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "pancreatic cancer"
}
]
}
]
},
{
"line": "* Concurrent investigational treatments.",
"criterions": [
{
"exact_snippets": "Concurrent investigational treatments",
"criterion": "investigational treatments",
"requirements": [
{
"requirement_type": "concurrency",
"expected_value": true
}
]
}
]
},
{
"line": "* Unresectable pancreatic mass.",
"criterions": [
{
"exact_snippets": "Unresectable pancreatic mass",
"criterion": "pancreatic mass",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": "unresectable"
}
]
}
]
},
{
"line": "* Neuroendocrine Histological pancreatic cancer",
"criterions": [
{
"exact_snippets": "Neuroendocrine Histological pancreatic cancer",
"criterion": "pancreatic cancer",
"requirements": [
{
"requirement_type": "histology",
"expected_value": "neuroendocrine"
}
]
}
]
},
{
"line": "* Distant Metastatic disease",
"criterions": [
{
"exact_snippets": "Distant Metastatic disease",
"criterion": "distant metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements",
"criterions": [
{
"exact_snippets": "Any condition that, in the option of the investigator, would compromise the well being of the patient",
"criterion": "condition compromising well-being",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "anything that would prevent the patient from meeting or performing study requirements",
"criterion": "ability to meet or perform study requirements",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}