{
"info": {
"nct_id": "NCT00514020",
"official_title": "Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study",
"inclusion_criteria": "* Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n\n * Metastatic disease\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan\n* No known active brain metastases\n\n * Patients with treated brain metastases are eligible if stable off steroids for at least 30 days\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)\n* Life expectancy ≥ 3 months\n* WBC ≥ 3,000/μL\n* Absolute neutrophil count ≥ 1,500/μL\n* Platelets ≥ 100,000/μL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)\n* Creatinine clearance ≤ 1.5 x ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 21 days after completion of study treatment\n* No history of allergic reactions to fluorouracil or oxaliplatin\n* No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior therapy for metastatic disease\n\n * Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months\n* No other concurrent chemotherapy\n* No concurrent combination anti-retroviral therapy for HIV-positive patients\n* No concurrent routine prophylaxis with filgrastim (G-CSF)\n* No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": ""
},
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"line": "* Metastatic disease",
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"unit": "mm"
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"line": "* WBC ≥ 3,000/μL",
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"unit": "μL"
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{
"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": "PATIENT CHARACTERISTICS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not pregnant or nursing",
"criterions": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Not pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "not ... nursing",
"criterion": "nursing",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction",
"criterions": [
{
"exact_snippets": "histologically or cytologically confirmed adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"stomach",
"gastroesophageal junction"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "histologically or cytologically confirmed adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically"
}
},
{
"exact_snippets": "histologically or cytologically confirmed adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "cytologically"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma location",
"requirement": {
"requirement_type": "location",
"expected_value": "stomach"
}
},
{
"exact_snippets": "adenocarcinoma of the stomach or gastroesophageal junction",
"criterion": "adenocarcinoma location",
"requirement": {
"requirement_type": "location",
"expected_value": "gastroesophageal junction"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance ≤ 1.5 x ULN",
"criterions": [
{
"exact_snippets": "Creatinine clearance ≤ 1.5 x ULN",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Creatinine clearance \u0010.5 x ULN",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN"
}
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}