{
    "info": {
        "nct_id": "NCT00343668",
        "official_title": "A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy",
        "inclusion_criteria": "* Pathologically proven unresectable adenocarcinoma of stomach\n* With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)\n* Age 18 to 70 years old\n* Estimated life expectancy of more than 3 months\n* ECOG performance status of 2 or lower\n* Adequate bone marrow function(absolute neutrophil count [ANC] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)\n* Adequate kidney function (serum creatinine < 1.5 mg/dL)\n* Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL)\n* No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)\n* No prior radiation therapy for at least 4 weeks before enrollment in the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Other tumor type than adenocarcinoma\n* Central nervous system (CNS) metastases or prior radiation for CNS metastases\n* Gastric outlet obstruction or intestinal obstruction\n* Evidence of gastrointestinal bleeding\n* The patient has bony lesions as the sole evaluable disease.\n* Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri\n* Pregnant or lactating women, women of childbearing potential not employing adequate contraception\n* Other serious illness or medical conditions\n\n  * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\n  * History of significant neurologic or psychiatric disorders including dementia or seizures\n  * Active uncontrolled infection\n  * Other serious underlying medical conditions which could impair the ability of the patient to participate in the study\n* Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy\n* concomitant drug medication; The following drugs cause drug interaction with S-1.\n\n  i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathologically proven unresectable adenocarcinoma of stomach",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pathologically proven"
                    ],
                    "criterion": "adenocarcinoma",
                    "requirement_type": "confirmation method",
                    "expected_value": "pathological"
                },
                {
                    "exact_snippets": [
                        "unresectable"
                    ],
                    "criterion": "adenocarcinoma",
                    "requirement_type": "resectability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "adenocarcinoma of stomach"
                    ],
                    "criterion": "adenocarcinoma",
                    "requirement_type": "location",
                    "expected_value": "stomach"
                }
            ]
        },
        {
            "line": "* With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)",
            "criterions": [
                {
                    "exact_snippets": [
                        "uni-dimensionally measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "longest diameter 2 cm on conventional CT scan, x-ray or physical examination"
                    ],
                    "criterion": "longest diameter",
                    "requirement_type": "minimum value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "1cm on spiral CT scan"
                    ],
                    "criterion": "longest diameter",
                    "requirement_type": "minimum value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Age 18 to 70 years old",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age 18 to 70 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            },
                            {
                                "operator": "<=",
                                "value": 70
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Estimated life expectancy of more than 3 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Estimated life expectancy",
                        "more than 3 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 3
                    }
                }
            ]
        },
        {
            "line": "* ECOG performance status of 2 or lower",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG performance status of 2 or lower"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function(absolute neutrophil count [ANC] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate bone marrow function",
                        "absolute neutrophil count [ANC] ≥1,500/µL"
                    ],
                    "criterion": "absolute neutrophil count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1500
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Adequate bone marrow function",
                        "hemoglobin ≥9.0 g/dL"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 9.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Adequate bone marrow function",
                        "platelets ≥100,000/µL"
                    ],
                    "criterion": "platelets",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Adequate kidney function (serum creatinine < 1.5 mg/dL)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate kidney function",
                        "serum creatinine < 1.5 mg/dL"
                    ],
                    "criterion": "kidney function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "serum creatinine < 1.5 mg/dL"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1.5
                    }
                }
            ]
        },
        {
            "line": "* Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate liver function"
                    ],
                    "criterion": "liver function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "serum total bilirubin < 2 times the upper normal limit (UNL)"
                    ],
                    "criterion": "serum total bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL"
                    ],
                    "criterion": "serum transaminases levels",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 3
                            },
                            {
                                "operator": "<",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)",
            "criterions": [
                {
                    "exact_snippets": [
                        "No prior chemotherapy"
                    ],
                    "criterion": "prior chemotherapy",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed"
                    ],
                    "criterion": "prior adjuvant chemotherapy",
                    "requirement_type": "completion time",
                    "expected_value": ">= 6 months before enrollment"
                },
                {
                    "exact_snippets": [
                        "prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded"
                    ],
                    "criterion": "prior adjuvant chemotherapy",
                    "requirement_type": "medication type",
                    "expected_value": [
                        "capecitabine",
                        "S-1",
                        "camptothecin analogues"
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiation therapy for at least 4 weeks before enrollment in the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "No prior radiation therapy"
                    ],
                    "criterion": "radiation therapy",
                    "requirement_type": "prior treatment",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "at least 4 weeks before enrollment"
                    ],
                    "criterion": "time since last radiation therapy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 70 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 70
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Other tumor type than adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": [
                        "Other tumor type than adenocarcinoma"
                    ],
                    "criterion": "tumor type",
                    "requirement_type": "exclusion",
                    "expected_value": "adenocarcinoma"
                }
            ]
        },
        {
            "line": "* Central nervous system (CNS) metastases or prior radiation for CNS metastases",
            "criterions": [
                {
                    "exact_snippets": [
                        "Central nervous system (CNS) metastases"
                    ],
                    "criterion": "CNS metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "prior radiation for CNS metastases"
                    ],
                    "criterion": "radiation for CNS metastases",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Gastric outlet obstruction or intestinal obstruction",
            "criterions": [
                {
                    "exact_snippets": [
                        "Gastric outlet obstruction"
                    ],
                    "criterion": "gastric outlet obstruction",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "intestinal obstruction"
                    ],
                    "criterion": "intestinal obstruction",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Evidence of gastrointestinal bleeding",
            "criterions": [
                {
                    "exact_snippets": [
                        "Evidence of gastrointestinal bleeding"
                    ],
                    "criterion": "gastrointestinal bleeding",
                    "requirement_type": "evidence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* The patient has bony lesions as the sole evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "bony lesions"
                    ],
                    "criterion": "bony lesions",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sole evaluable disease"
                    ],
                    "criterion": "evaluable disease",
                    "requirement_type": "type",
                    "expected_value": "bony lesions"
                }
            ]
        },
        {
            "line": "* Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri",
            "criterions": [
                {
                    "exact_snippets": [
                        "Past or concurrent history of neoplasm other than stomach cancer"
                    ],
                    "criterion": "neoplasm",
                    "requirement_type": "history",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "curatively treated non-melanoma skin cancer"
                    ],
                    "criterion": "non-melanoma skin cancer",
                    "requirement_type": "treatment status",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "in situ carcinoma of the cervix uteri"
                    ],
                    "criterion": "carcinoma of the cervix uteri",
                    "requirement_type": "stage",
                    "expected_value": "in situ"
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women, women of childbearing potential not employing adequate contraception",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactating women"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "women of childbearing potential",
                        "not employing adequate contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Other serious illness or medical conditions",
            "criterions": [
                {
                    "exact_snippets": [
                        "serious illness"
                    ],
                    "criterion": "illness",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "medical conditions"
                    ],
                    "criterion": "medical conditions",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unstable cardiac disease"
                    ],
                    "criterion": "cardiac disease",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "myocardial infarction within 6 months prior to study entry"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "time since occurrence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* History of significant neurologic or psychiatric disorders including dementia or seizures",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of significant neurologic or psychiatric disorders"
                    ],
                    "criterion": "neurologic disorders",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "History of significant neurologic or psychiatric disorders"
                    ],
                    "criterion": "psychiatric disorders",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "including dementia"
                    ],
                    "criterion": "dementia",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "including",
                        "seizures"
                    ],
                    "criterion": "seizures",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Active uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "control status",
                    "expected_value": "uncontrolled"
                }
            ]
        },
        {
            "line": "* Other serious underlying medical conditions which could impair the ability of the patient to participate in the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "serious underlying medical conditions"
                    ],
                    "criterion": "underlying medical conditions",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "impair the ability of the patient to participate in the study"
                    ],
                    "criterion": "ability to participate in the study",
                    "requirement_type": "impairment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* concomitant drug medication; The following drugs cause drug interaction with S-1.",
            "criterions": [
                {
                    "exact_snippets": [
                        "concomitant drug medication"
                    ],
                    "criterion": "concomitant drug medication",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "The following drugs cause drug interaction with S-1"
                    ],
                    "criterion": "drug interaction with S-1",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Warfarin, phenprocoumon: increase bleeding tendency"
                    ],
                    "criterion": "Warfarin, phenprocoumon",
                    "requirement_type": "effect",
                    "expected_value": "increase bleeding tendency"
                },
                {
                    "exact_snippets": [
                        "Increase blood concentration of phenytoin"
                    ],
                    "criterion": "phenytoin",
                    "requirement_type": "blood concentration",
                    "expected_value": "increase"
                },
                {
                    "exact_snippets": [
                        "sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine"
                    ],
                    "criterion": "sorivudine",
                    "requirement_type": "interaction",
                    "expected_value": "inhibit DPD -> increase toxicity according to fluoropyrimidine"
                },
                {
                    "exact_snippets": [
                        "allopurinol : decrease activity of S-1"
                    ],
                    "criterion": "allopurinol",
                    "requirement_type": "effect",
                    "expected_value": "decrease activity of S-1"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Concomitant administration of any other experimental drug under investigation"
                    ],
                    "criterion": "experimental drug",
                    "requirement_type": "concomitant administration",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "concomitant chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "concomitant administration",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "concomitant hormonal therapy"
                    ],
                    "criterion": "hormonal therapy",
                    "requirement_type": "concomitant administration",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "concomitant immunotherapy"
                    ],
                    "criterion": "immunotherapy",
                    "requirement_type": "concomitant administration",
                    "expected_value": false
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}