{
    "info": {
        "nct_id": "NCT01100801",
        "official_title": "A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients",
        "inclusion_criteria": "* Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated\n* Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array\n* At least one measurable defined by RECIST\n* Age >=21 years old\n* Performance status (ECOG) 0-2\n* Life expectancy >3 months\n* No significant problems for oral intake and drug administration\n* Adequate organ functions:\n\nbone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl) renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min) hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with liver metastasis)\n\n* Recovery from relevant toxicity to previous treatment before study entry\n* Ability to understand and willingness to sign a written informed consent before study entry\nHealthy volunteers allowed\nMust have minimum age of 21 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study\n* Prior radiotherapy was administered to target lesions selected for this study\n* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)\n* Presence of symptomatic or progressing CNS metastasis\n* Serious illness or medical conditions:\n\nCongestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 3 months Hepatic cirrhosis (= Child class B) Psychiatric disorder that may interfere with protocol compliance Active infection\n\n* Known hypersensitivity to platinum or fluoropyrimidine.\n* Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method\n* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential\n* Any patients judged by the investigator to be unfit to participate in the study\n* Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in- vitro sensitivity array",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically documented",
                    "criterion": "documentation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced, metastatic or recurrent gastric cancer",
                    "criterion": "gastric cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "convention therapy of a platinum/fluoropyrimidine combination is indicated",
                    "criterion": "therapy indication",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "platinum/fluoropyrimidine combination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array",
            "criterions": [
                {
                    "exact_snippets": "Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature",
                    "criterion": "tumour expression signature",
                    "requirements": [
                        {
                            "requirement_type": "predicted response",
                            "expected_value": "responder to platinum and fluoropyrimidine"
                        }
                    ]
                },
                {
                    "exact_snippets": "derived from in-vitro sensitivity array",
                    "criterion": "in-vitro sensitivity array",
                    "requirements": [
                        {
                            "requirement_type": "derivation",
                            "expected_value": "tumour expression signature"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable defined by RECIST",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable defined by RECIST",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >=21 years old",
            "criterions": [
                {
                    "exact_snippets": "Age >=21 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status (ECOG) 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance status (ECOG) 0-2",
                    "criterion": "performance status (ECOG)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy >3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant problems for oral intake and drug administration",
            "criterions": [
                {
                    "exact_snippets": "No significant problems for oral intake",
                    "criterion": "oral intake",
                    "requirements": [
                        {
                            "requirement_type": "problems",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No significant problems for ... drug administration",
                    "criterion": "drug administration",
                    "requirements": [
                        {
                            "requirement_type": "problems",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ functions:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ functions",
                    "criterion": "organ functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovery from relevant toxicity to previous treatment before study entry",
            "criterions": [
                {
                    "exact_snippets": "Recovery from relevant toxicity to previous treatment",
                    "criterion": "toxicity from previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign a written informed consent before study entry",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy for gastric cancer",
                    "criterion": "prior chemotherapy for gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except neoadjuvant or adjuvant systemic therapy",
                    "criterion": "neoadjuvant or adjuvant systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "terminated at least 6 months before the start of treatment in this study",
                    "criterion": "termination of neoadjuvant or adjuvant systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since termination",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiotherapy was administered to target lesions selected for this study",
            "criterions": [
                {
                    "exact_snippets": "Prior radiotherapy was administered to target lesions",
                    "criterion": "prior radiotherapy to target lesions",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)",
            "criterions": [
                {
                    "exact_snippets": "Second primary malignancy",
                    "criterion": "second primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell carcinoma of the skin",
                    "criterion": "adequately treated basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior malignancy treated more than 5 years ago without recurrence",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated more than 5 years ago"
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of symptomatic or progressing CNS metastasis",
            "criterions": [
                {
                    "exact_snippets": "Presence of symptomatic or progressing CNS metastasis",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "progressing",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious illness or medical conditions:",
            "criterions": [
                {
                    "exact_snippets": "Serious illness or medical conditions",
                    "criterion": "serious illness or medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 3 months Hepatic cirrhosis (= Child class B) Psychiatric disorder that may interfere with protocol compliance Active infection",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure (NYHA class III or IV)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NYHA class III",
                                "NYHA class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past 3 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic cirrhosis (= Child class B)",
                    "criterion": "hepatic cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Child class B"
                        }
                    ]
                },
                {
                    "exact_snippets": "Psychiatric disorder that may interfere with protocol compliance",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "impact on protocol compliance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to platinum or fluoropyrimidine.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to platinum",
                    "criterion": "hypersensitivity to platinum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... fluoropyrimidine",
                    "criterion": "hypersensitivity to fluoropyrimidine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating woman",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of child bearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "contraceptive use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential",
            "criterions": [
                {
                    "exact_snippets": "Sexually active fertile men",
                    "criterion": "fertility status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "not using effective birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "up to 6 months after completion of study drug",
                    "criterion": "duration of birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "up to 6 months after completion of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "if their partners are women of child-bearing potential",
                    "criterion": "partner's child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": "child-bearing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any patients judged by the investigator to be unfit to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "judged by the investigator to be unfit to participate in the study",
                    "criterion": "fitness to participate",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "fit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in- vitro sensitivity array",
            "criterions": [
                {
                    "exact_snippets": "Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature",
                    "criterion": "response to platinum and fluoropyrimidine",
                    "requirements": [
                        {
                            "requirement_type": "predicted response",
                            "expected_value": "non-responder"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumour expression signature derived from in- vitro sensitivity array",
                    "criterion": "tumour expression signature",
                    "requirements": [
                        {
                            "requirement_type": "derivation method",
                            "expected_value": "in-vitro sensitivity array"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "bone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl) renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min) hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with liver metastasis)",
            "criterions": [
                {
                    "exact_snippets": "bone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl)",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "ANC",
                            "expected_value": {
                                "operator": "=",
                                "value": 1500,
                                "unit": "uL"
                            }
                        },
                        {
                            "requirement_type": "Platelet",
                            "expected_value": {
                                "operator": "=",
                                "value": 100000,
                                "unit": "uL"
                            }
                        },
                        {
                            "requirement_type": "Hb",
                            "expected_value": {
                                "operator": "=",
                                "value": 8.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min)",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "serum creatinine",
                            "expected_value": "= UNL"
                        },
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": "=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x UNL and AST/ALT levels < 5 x ULN with liver metastasis)",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "Total bilirubin",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "x UNL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "AST/ALT levels",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "Total bilirubin with liver metastasis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "x UNL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "AST/ALT levels with liver metastasis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}