{
    "info": {
        "nct_id": "NCT00003862",
        "official_title": "A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 0 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically proven adenocarcinoma of the stomach\n\n  * Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)\n\n    * No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)\n  * Potentially resectable\n  * May involve the gastroesophageal junction, but bulk of tumor must be in the stomach\n  * No distant metastases\n  * No pleural or pericardial effusion\n* No peritoneal disease diagnosed by laparoscopy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* At least 16 weeks\n\nHematopoietic:\n\n* Absolute granulocyte count greater than 2,000/mm^3\n* Platelet count greater than 100,000/mm^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL\n\nCardiovascular:\n\n* No New York Heart Association class III or IV heart disease\n* No hypertension\n\nNeurologic:\n\n* No cerebrovascular disease\n* No diabetic neuropathy\n* No mental status abnormalities\n\nOther:\n\n* No uncontrolled diabetes\n* No infection\n* No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior immunotherapy\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to stomach\n\nSurgery:\n\n* No prior surgery to stomach"
    },
    "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 0 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 0 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically proven adenocarcinoma of the stomach",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven adenocarcinoma of the stomach",
                    "criterion": "adenocarcinoma of the stomach",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)",
            "criterions": [
                {
                    "exact_snippets": "Stage IB, II, IIIA, IIIB, and IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IB",
                                "II",
                                "IIIA",
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "T2-3",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "T stage",
                            "expected_value": "T2-3"
                        }
                    ]
                },
                {
                    "exact_snippets": "any N",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "N stage",
                            "expected_value": "any N"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "M stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)",
            "criterions": [
                {
                    "exact_snippets": "No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)",
                    "criterion": "lymph node metastases",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "within the field of resection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Potentially resectable",
            "criterions": [
                {
                    "exact_snippets": "Potentially resectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "potentially"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May involve the gastroesophageal junction, but bulk of tumor must be in the stomach",
            "criterions": [
                {
                    "exact_snippets": "May involve the gastroesophageal junction",
                    "criterion": "gastroesophageal junction involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bulk of tumor must be in the stomach",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "stomach"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No distant metastases",
            "criterions": [
                {
                    "exact_snippets": "No distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No pleural or pericardial effusion",
            "criterions": [
                {
                    "exact_snippets": "No pleural or pericardial effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No pleural or pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No peritoneal disease diagnosed by laparoscopy",
            "criterions": [
                {
                    "exact_snippets": "No peritoneal disease diagnosed by laparoscopy",
                    "criterion": "peritoneal disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Zubrod 0-2",
            "criterions": [
                {
                    "exact_snippets": "Zubrod 0-2",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 16 weeks",
            "criterions": [
                {
                    "exact_snippets": "At least 16 weeks",
                    "criterion": "duration",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute granulocyte count greater than 2,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocyte count greater than 2,000/mm^3",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count greater than 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count greater than 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine less than 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine less than 1.5 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III or IV heart disease",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III or IV heart disease",
                    "criterion": "New York Heart Association heart disease class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No hypertension",
            "criterions": [
                {
                    "exact_snippets": "No hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Neurologic:",
            "criterions": [
                {
                    "exact_snippets": "Neurologic:",
                    "criterion": "neurologic condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No cerebrovascular disease",
            "criterions": [
                {
                    "exact_snippets": "No cerebrovascular disease",
                    "criterion": "cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No diabetic neuropathy",
            "criterions": [
                {
                    "exact_snippets": "No diabetic neuropathy",
                    "criterion": "diabetic neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No mental status abnormalities",
            "criterions": [
                {
                    "exact_snippets": "No mental status abnormalities",
                    "criterion": "mental status",
                    "requirements": [
                        {
                            "requirement_type": "abnormalities",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled diabetes",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No infection",
            "criterions": [
                {
                    "exact_snippets": "No infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other malignancies within past 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except resected squamous cell or basal cell skin cancer",
                    "criterion": "resected squamous cell or basal cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior immunotherapy",
                    "criterion": "prior immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to stomach",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to stomach",
                    "criterion": "radiotherapy to stomach",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery:",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior surgery to stomach",
            "criterions": [
                {
                    "exact_snippets": "No prior surgery to stomach",
                    "criterion": "prior surgery to stomach",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        }
    ]
}