{
    "info": {
        "nct_id": "NCT00359476",
        "official_title": "A Multicenter, Single-Arm, Phase II Study of Single-Agent Vinflunine in the Second-line Treatment of Patients With Gastric Cancer",
        "inclusion_criteria": "* Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.\n* EGOC performance status of 0,1 or 2\n* Men and women, 18 years of age and older\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients having received more than one previous systemic chemotherapy regimen in any setting.\n* Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks\n* Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)\n* Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment\n* Acute or chronic hepatitis\n* Known HIV infection\n* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms\n* A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.",
                "criterions": [
                    {
                        "exact_snippets": "locally advanced or metastatic gastric adenocarcinoma",
                        "criterion": "gastric adenocarcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "adenocarcinoma of the gastroesophageal junction",
                        "criterion": "adenocarcinoma of the gastroesophageal junction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progressed on a fluoropyrimidine or taxane-containing regimen",
                        "criterion": "progression on fluoropyrimidine or taxane-containing regimen",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "one prior first line treatment",
                        "criterion": "prior first line treatment",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "prior first line treatment"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "locally advanced or metastatic gastric adenocarcinoma",
                                        "criterion": "gastric adenocarcinoma",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": [
                                                "locally advanced",
                                                "metastatic"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "progressed on a fluoropyrimidine or taxane-containing regimen",
                                        "criterion": "progression on fluoropyrimidine or taxane-containing regimen",
                                        "requirement": {
                                            "requirement_type": "progression",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "one prior first line treatment",
                                        "criterion": "prior first line treatment",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 1,
                                                "unit": "prior first line treatment"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "adenocarcinoma of the gastroesophageal junction",
                                "criterion": "adenocarcinoma of the gastroesophageal junction",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* EGOC performance status of 0,1 or 2",
                "criterions": [
                    {
                        "exact_snippets": "EGOC performance status of 0,1 or 2",
                        "criterion": "EGOC performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "EGOC performance status of 0,1 or 2",
                        "criterion": "EGOC performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Men and women, 18 years of age and older",
                "criterions": [
                    {
                        "exact_snippets": "Men and women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "18 years of age and older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Men and women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "18 years of age and older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients having received more than one previous systemic chemotherapy regimen in any setting.",
                "criterions": [
                    {
                        "exact_snippets": "Patients having received more than one previous systemic chemotherapy regimen",
                        "criterion": "previous systemic chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients having received more than one previous systemic chemotherapy regimen",
                        "criterion": "previous systemic chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks",
                "criterions": [
                    {
                        "exact_snippets": "Major abdominal surgery within 2 months",
                        "criterion": "major abdominal surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any other surgery under general anesthesia within 4 weeks",
                        "criterion": "surgery under general anesthesia",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Major abdominal surgery within 2 months",
                        "criterion": "major abdominal surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any other surgery under general anesthesia within 4 weeks",
                        "criterion": "surgery under general anesthesia",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)",
                "criterions": [
                    {
                        "exact_snippets": "Unresolved occlusive or sub-occlusive intestinal disease",
                        "criterion": "occlusive or sub-occlusive intestinal disease",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any significant chronic intestinal disease (e.g. ulcerative colitis)",
                        "criterion": "chronic intestinal disease",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Unresolved occlusive or sub-occlusive intestinal disease",
                                "criterion": "occlusive or sub-occlusive intestinal disease",
                                "requirement": {
                                    "requirement_type": "resolution",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "any significant chronic intestinal disease (e.g. ulcerative colitis)",
                                "criterion": "chronic intestinal disease",
                                "requirement": {
                                    "requirement_type": "significance",
                                    "expected_value": "significant"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior radiation to >=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment",
                "criterions": [
                    {
                        "exact_snippets": "Prior radiation to >=30% of the bone marrow",
                        "criterion": "radiation to bone marrow",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior radiation to >=30% of the bone marrow",
                        "criterion": "radiation to bone marrow",
                        "requirement": {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiation within 4 weeks prior to enrollment",
                        "criterion": "radiation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to enrollment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior radiation to >=30% of the bone marrow",
                                "criterion": "radiation to bone marrow",
                                "requirement": {
                                    "requirement_type": "extent",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Prior radiation to >=30% of the bone marrow",
                                "criterion": "radiation to bone marrow",
                                "requirement": {
                                    "requirement_type": "prior",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "radiation within 4 weeks prior to enrollment",
                        "criterion": "radiation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to enrollment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known HIV infection",
                "criterions": [
                    {
                        "exact_snippets": "Known HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms",
                "criterions": [
                    {
                        "exact_snippets": "baseline prolongation of QT/QTc interval ... QTc interval >450 ms",
                        "criterion": "QT/QTc interval",
                        "requirement": {
                            "requirement_type": "prolongation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline prolongation of QT/QTc interval ... QTc interval >450 ms",
                        "criterion": "QT/QTc interval",
                        "requirement": {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "baseline prolongation of QT/QTc interval ... QTc interval >450 ms",
                        "criterion": "QT/QTc interval",
                        "requirement": {
                            "requirement_type": "prolongation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline prolongation of QT/QTc interval ... QTc interval >450 ms",
                        "criterion": "QT/QTc interval",
                        "requirement": {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)",
                "criterions": [
                    {
                        "exact_snippets": "A history of additional risk factors for Torsade de Pointes",
                        "criterion": "risk factors for Torsade de Pointes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypokalemia",
                        "criterion": "hypokalemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of Long QT Syndrome",
                        "criterion": "family history of Long QT Syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "A history of additional risk factors for Torsade de Pointes",
                                "criterion": "risk factors for Torsade de Pointes",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "heart failure",
                                "criterion": "heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "hypokalemia",
                                "criterion": "hypokalemia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "family history of Long QT Syndrome",
                                "criterion": "family history of Long QT Syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "heart failure",
                        "criterion": "heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypokalemia",
                        "criterion": "hypokalemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of Long QT Syndrome",
                        "criterion": "family history of Long QT Syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Acute or chronic hepatitis",
                "criterions": [
                    {
                        "exact_snippets": "Acute or chronic hepatitis",
                        "criterion": "hepatitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Acute or chronic hepatitis",
                        "criterion": "hepatitis",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Acute or chronic hepatitis",
                                "criterion": "hepatitis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Acute or chronic hepatitis",
                                        "criterion": "hepatitis",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "acute"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Acute or chronic hepatitis",
                                        "criterion": "hepatitis",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "chronic"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}