{
    "info": {
        "nct_id": "NCT00003172",
        "official_title": "Randomized Phase II Trial of Either 5-Fluorouracil, Recombinant Alfa-2a-Interferon and Intravenous Hydroxyurea With Filgrastim Support (FHIG) or Doxorubicin/Docetaxel (Dd) in Patients With Advanced Gastric Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction beyond the scope of surgical resection Must have measurable disease in either one or two dimensions either radiographically or by physical examination Measurable disease must be documented outside of a prior radiation portal Evaluable disease only not allowed\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No chronic or unstable angina No uncontrolled congestive heart failure No arrhythmia No chronic angina No myocardial infarction in the past 1 year If history of atherosclerotic heart disease, prior cardiac catheterization or thallium stress test must not suggest coronary artery disease Neurology: No symptomatic peripheral neuropathy greater than grade 2 No cerebellar disease No seizure disorder No organic mental syndrome No major psychoaffective disorder Pulmonary: No chronic obstructive pulmonary disease No chronic bronchitis, emphysema, sarcoid, or bronchiectasis Other: No poorly controlled diabetes mellitus No psychiatric illness No active infections, including AIDS, ARC, or HIV positive No history of hypersensitivity to products containing Polysorbate 80 No history of uncontrolled alcohol or drug abuse No uncontrolled hypercalcemia No other prior malignancy within the past 5 years other than nonmelanomatous skin cancer or cervical carcinoma in situ Not pregnant or nursing Adequate contraception required of all fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy Endocrine therapy: No chronic use of steroids No concurrent hormonal therapy (except birth control pills) Radiotherapy: At least 1 month since prior radiotherapy No concurrent palliative radiotherapy (arm I patients) Surgery: Must have fully recovered from surgery Other: At least 4 weeks since other investigational agents and recovered from all toxic effects No chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction beyond the scope of surgical resection Must have measurable disease in either one or two dimensions either radiographically or by physical examination Measurable disease must be documented outside of a prior radiation portal Evaluable disease only not allowed",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "stomach",
                                "gastroesophageal junction"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "beyond the scope of surgical resection",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "scope",
                            "expected_value": "beyond"
                        }
                    ]
                },
                {
                    "exact_snippets": "Must have measurable disease in either one or two dimensions",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "dimensions",
                            "expected_value": "one or two"
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease must be documented outside of a prior radiation portal",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "outside of a prior radiation portal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Evaluable disease only not allowed",
                    "criterion": "evaluable disease",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No chronic or unstable angina No uncontrolled congestive heart failure No arrhythmia No chronic angina No myocardial infarction in the past 1 year If history of atherosclerotic heart disease, prior cardiac catheterization or thallium stress test must not suggest coronary artery disease Neurology: No symptomatic peripheral neuropathy greater than grade 2 No cerebellar disease No seizure disorder No organic mental syndrome No major psychoaffective disorder Pulmonary: No chronic obstructive pulmonary disease No chronic bronchitis, emphysema, sarcoid, or bronchiectasis Other: No poorly controlled diabetes mellitus No psychiatric illness No active infections, including AIDS, ARC, or HIV positive No history of hypersensitivity to products containing Polysorbate 80 No history of uncontrolled alcohol or drug abuse No uncontrolled hypercalcemia No other prior malignancy within the past 5 years other than nonmelanomatous skin cancer or cervical carcinoma in situ Not pregnant or nursing Adequate contraception required of all fertile patients",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0-1",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": [
                                "ECOG 0",
                                "ECOG 1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: Not specified",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: WBC greater than 4,000/mm3",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count greater than 1,500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count greater than 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT no greater than 1.5 times ULN",
                    "criterion": "SGOT level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase no greater than 5 times ULN",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine less than 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: No New York Heart Association class III or IV heart disease",
                    "criterion": "New York Heart Association heart disease class",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "class III",
                                "class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No chronic or unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "chronic",
                                "unstable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No uncontrolled congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "No arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No chronic angina",
                    "criterion": "chronic angina",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No myocardial infarction in the past 1 year",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If history of atherosclerotic heart disease, prior cardiac catheterization or thallium stress test must not suggest coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "not suggestive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Neurology: No symptomatic peripheral neuropathy greater than grade 2",
                    "criterion": "symptomatic peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No cerebellar disease",
                    "criterion": "cerebellar disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No seizure disorder",
                    "criterion": "seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No organic mental syndrome",
                    "criterion": "organic mental syndrome",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No major psychoaffective disorder",
                    "criterion": "major psychoaffective disorder",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pulmonary: No chronic obstructive pulmonary disease",
                    "criterion": "chronic obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No chronic bronchitis, emphysema, sarcoid, or bronchiectasis",
                    "criterion": "chronic pulmonary conditions",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "chronic bronchitis",
                                "emphysema",
                                "sarcoid",
                                "bronchiectasis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No poorly controlled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "well controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "No psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No active infections, including AIDS, ARC, or HIV positive",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "AIDS",
                                "ARC",
                                "HIV positive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of hypersensitivity to products containing Polysorbate 80",
                    "criterion": "hypersensitivity to Polysorbate 80",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of uncontrolled alcohol or drug abuse",
                    "criterion": "alcohol or drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "No uncontrolled hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "No other prior malignancy within the past 5 years other than nonmelanomatous skin cancer or cervical carcinoma in situ",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "nonmelanomatous skin cancer",
                                "cervical carcinoma in situ"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant or nursing",
                    "criterion": "pregnancy or nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant or nursing"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate contraception required of all fertile patients",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "adequate contraception"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy Endocrine therapy: No chronic use of steroids No concurrent hormonal therapy (except birth control pills) Radiotherapy: At least 1 month since prior radiotherapy No concurrent palliative radiotherapy (arm I patients) Surgery: Must have fully recovered from surgery Other: At least 4 weeks since other investigational agents and recovered from all toxic effects No chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens",
            "criterions": [
                {
                    "exact_snippets": "No concurrent immunotherapy",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior systemic chemotherapy",
                    "criterion": "prior systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No chronic use of steroids",
                    "criterion": "chronic use of steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent hormonal therapy (except birth control pills)",
                    "criterion": "concurrent hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 1 month since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent palliative radiotherapy (arm I patients)",
                    "criterion": "concurrent palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Must have fully recovered from surgery",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks since other investigational agents and recovered from all toxic effects",
                    "criterion": "time since other investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks since other investigational agents and recovered from all toxic effects",
                    "criterion": "recovery from toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens",
                    "criterion": "chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}