{
"info": {
"nct_id": "NCT01726582",
"official_title": "A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant Therapy for Resectable and Borderline Resectable Adenocarcinoma of the Pancreas",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "Any patient with one or more of the following will be excluded:\n\n* Have received chemotherapy or chemoradiation within 5 years prior of study enrollment\n* Have any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study enrollment\n* Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent\n* Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection\n* Pregnant or breast-feeding patients or any patient with child-bearing potential not using contraception 4 weeks prior to, during and 4 months after study treatment is discontinued",
"miscellaneous_criteria": "Inclusion criteria:\n\n* 18 years of age or older\n* Able to understand and provide written informed consent\n* Diagnosis of adenocarcinoma of the pancreas or high suspicion of adenocarcinoma of the pancreas based on CT and MRI findings as detailed below by \"Definition of....\"\n\nTreatment Eligibility Criteria:\n\n* Have an Eastern Cooperative Oncology Group performance status less than or equal to 2\n* Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas\n* Have adequate organ and bone marrow function as defined by:\n\n * total leukocytes greater than or equal to 3 x1000/μL\n * absolute neutrophil count (ANC) > or equal to 1.5x 1000/μL\n * hemoglobin > or equal to 9 g/dL\n * platelets > or equal to 100 x 1000/μL\n * creatinine clearance >60 mL/min or creatinine < or equal to 1.5 mg/dL\n * bilirubin < or equal to 2 mg/dL or >2 and declining as described in the protocol\n * aspartate transaminases (AST/SGOT) < or equal to3 x upper limit of normal (ULN)\n * alanine transaminases (ALT/SGPT) < or equal to 3 x ULN\n* Female patients must be post menopausal for > 1 year, surgically sterile, or have a negative pregnancy test and used at least one form of contraception for 4 weeks prior to Day 1 of the study, during study treatment and during the first 4 months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for 4 months after the last dose of any study drug.\n\nDefinition of Resectable Pancreatic Cancer includes:\n\n* No evidence of extra-pancreatic disease\n* No evidence of tumor-arterial abutment (celiac, superior mesenteric artery or hepatic artery)\n* If tumor induced narrowing of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence is present it must be <50% of the diameter of the vessel\n* Ca19-9 <5000, when bilirubin is <2 (or >2 and declining as described in the protocol)\n\nDefinition of Borderline Resectable Pancreatic Cancer to include at least one of the following:\n\n* Tumor abutment < or equal to 180 degrees of the superior mesenteric artery or celiac axis\n* Tumor abutment or encasement (>180 degrees) of a short segment of the hepatic artery\n* Tumor induced narrowing of superior mesenteric vein, portal vein or superior mesenteric-portal vein of >50% of the diameter of the vessel.\n* Short segment occlusion of the superior mesenteric vein, portal vein or superior mesenteric-portal vein confluence with a suitable portal vein above and superior mesenteric vein below, for reconstruction\n* CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic cancer conference)\n* Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound-guided fine needle aspirate\n* Resectable tumor and cancer antigen 19-9 (CA19-9) >5000"
},
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}
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"requirement_type": "location",
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}
},
{
"exact_snippets": "suitable ... superior mesenteric vein below",
"criterion": "suitable superior mesenteric vein",
"requirement": {
"requirement_type": "location",
"expected_value": "below"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Short segment occlusion of the superior mesenteric vein",
"criterion": "superior mesenteric vein occlusion",
"requirement": {
"requirement_type": "severity",
"expected_value": "short segment"
}
},
{
"exact_snippets": "suitable portal vein above",
"criterion": "suitable portal vein",
"requirement": {
"requirement_type": "location",
"expected_value": "above"
}
},
{
"exact_snippets": "suitable ... superior mesenteric vein below",
"criterion": "suitable superior mesenteric vein",
"requirement": {
"requirement_type": "location",
"expected_value": "below"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Short segment occlusion of the ... portal vein",
"criterion": "portal vein occlusion",
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"requirement_type": "severity",
"expected_value": "short segment"
}
},
{
"exact_snippets": "suitable portal vein above",
"criterion": "suitable portal vein",
"requirement": {
"requirement_type": "location",
"expected_value": "above"
}
},
{
"exact_snippets": "suitable ... superior mesenteric vein below",
"criterion": "suitable superior mesenteric vein",
"requirement": {
"requirement_type": "location",
"expected_value": "below"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Short segment occlusion of the ... superior mesenteric-portal vein confluence",
"criterion": "superior mesenteric-portal vein confluence occlusion",
"requirement": {
"requirement_type": "severity",
"expected_value": "short segment"
}
},
{
"exact_snippets": "suitable portal vein above",
"criterion": "suitable portal vein",
"requirement": {
"requirement_type": "location",
"expected_value": "above"
}
},
{
"exact_snippets": "suitable ... superior mesenteric vein below",
"criterion": "suitable superior mesenteric vein",
"requirement": {
"requirement_type": "location",
"expected_value": "below"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* CT or MRI findings suspicious for, but not diagnostic of, metastatic disease (based on multidisciplinary assessment at the Medical College of Wisconsin weekly pancreatic cancer conference)",
"criterions": [
{
"exact_snippets": "CT or MRI findings suspicious for, but not diagnostic of, metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "diagnostic status",
"expected_value": "suspicious but not diagnostic"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "CT or MRI findings suspicious for, but not diagnostic of, metastatic disease",
"criterion": "metastatic disease",
"requirement": {
"requirement_type": "diagnostic status",
"expected_value": "suspicious but not diagnostic"
}
}
]
}
},
{
"identified_line": {
"line": "* Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or endoscopic ultrasound-guided fine needle aspirate",
"criterions": [
{
"exact_snippets": "Biopsy proven N1 disease (regional lymph nodes involved)",
"criterion": "N1 disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pre-referral biopsy",
"criterion": "pre-referral biopsy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "endoscopic ultrasound-guided fine needle aspirate",
"criterion": "endoscopic ultrasound-guided fine needle aspirate",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Biopsy proven N1 disease (regional lymph nodes involved)",
"criterion": "N1 disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pre-referral biopsy",
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"requirement_type": "presence",
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]
},
{
"and_criteria": [
{
"exact_snippets": "Biopsy proven N1 disease (regional lymph nodes involved)",
"criterion": "N1 disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "endoscopic ultrasound-guided fine needle aspirate",
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"requirement_type": "presence",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Resectable tumor and cancer antigen 19-9 (CA19-9) >5000",
"criterions": [
{
"exact_snippets": "Resectable tumor",
"criterion": "tumor",
"requirement": {
"requirement_type": "resectability",
"expected_value": true
}
},
{
"exact_snippets": "cancer antigen 19-9 (CA19-9) >5000",
"criterion": "cancer antigen 19-9 (CA19-9)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 5000,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Resectable tumor",
"criterion": "tumor",
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"requirement_type": "resectability",
"expected_value": true
}
},
{
"exact_snippets": "cancer antigen 19-9 (CA19-9) >5000",
"criterion": "cancer antigen 19-9 (CA19-9)",
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"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 5000,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "Inclusion criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Treatment Eligibility Criteria:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Have biopsy-proven resectable or borderline resectable adenocarcinoma of the pancreas",
"criterions": [
{
"exact_snippets": "biopsy-proven",
"criterion": "biopsy",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "resectable or borderline resectable",
"criterion": "resectability",
"requirement": {
"requirement_type": "status",
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"resectable",
"borderline resectable"
]
}
},
{
"exact_snippets": "adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma of the pancreas",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "biopsy-proven",
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}
},
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"or_criteria": [
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"exact_snippets": "resectable or borderline resectable",
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}
},
{
"exact_snippets": "resectable or borderline resectable",
"criterion": "resectability",
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"requirement_type": "status",
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}
}
]
}
]
},
{
"exact_snippets": "adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma of the pancreas",
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"requirement_type": "presence",
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}
}
]
}
},
{
"identified_line": {
"line": "* No evidence of extra-pancreatic disease",
"criterions": [
{
"exact_snippets": "No evidence of extra-pancreatic disease",
"criterion": "extra-pancreatic disease",
"requirement": {
"requirement_type": "presence",
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}
}
]
},
"logical_structure": {
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"requirement": {
"requirement_type": "presence",
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}
}
}
}
]
}