{
    "info": {
        "nct_id": "NCT02356276",
        "official_title": "A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2",
        "inclusion_criteria": "* 18 < age ≤ 70 years old\n* Male or Non pregnant female\n* The Eastern Cooperative Oncology Group (ECOG) status 0-1\n* T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition)\n* No distance metastasis, eligible for D2 lymphadenectomy\n* Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy\n* White blood cells > 4,000/mm3\n* neutrophils ≥ 1,500/mm3\n* platelets ≥ 100,000/mm3\n* hemoglobin>9g/l\n* Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)\n* total bilirubin (TBIL) < 1.5 times ULN\n* serum creatinine < 1 times ULN\n* Having given written informed consent prior to any procedure related to the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Have other cancer within 5 years\n* Existence of distance metastasis during surgey (M1)\n* Prior malignant tumors with detectable signs of recurrence or distant metastasis\n* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%\n* Epileptic seizures patients need medicine control\n* Uncontroled mental disease or mental disorder\n* Drug abuse or psychological or social factors affect the judgment of results\n* Contraindication to any therapy contained in this regimen specific to the study\n* Receiving other chemotherapy, radiotherapy or immunotherapy\n* Without given written informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18 < age ≤ 70 years old",
            "criterions": [
                {
                    "exact_snippets": "18 < age ≤ 70 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male or Non pregnant female",
            "criterions": [
                {
                    "exact_snippets": "Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "Non pregnant female",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "non-pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Non pregnant female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The Eastern Cooperative Oncology Group (ECOG) status 0-1",
            "criterions": [
                {
                    "exact_snippets": "The Eastern Cooperative Oncology Group (ECOG) status 0-1",
                    "criterion": "ECOG status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition)",
            "criterions": [
                {
                    "exact_snippets": "T3 or T4 gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T3",
                                "T4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "visual determination according to AJCC 2010 7th edition",
                    "criterion": "AJCC 2010 7th edition",
                    "requirements": [
                        {
                            "requirement_type": "determination method",
                            "expected_value": "visual"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No distance metastasis, eligible for D2 lymphadenectomy",
            "criterions": [
                {
                    "exact_snippets": "No distance metastasis",
                    "criterion": "distance metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for D2 lymphadenectomy",
                    "criterion": "D2 lymphadenectomy eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "Have not received cytotoxic chemotherapy",
                    "criterion": "cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Have not received ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Have not received ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cells > 4,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "White blood cells > 4,000/mm3",
                    "criterion": "white blood cells",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 4000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* neutrophils ≥ 1,500/mm3",
            "criterions": [
                {
                    "exact_snippets": "neutrophils ≥ 1,500/mm3",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelets ≥ 100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "platelets ≥ 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hemoglobin>9g/l",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin>9g/l",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* total bilirubin (TBIL) < 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin (TBIL) < 1.5 times ULN",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* serum creatinine < 1 times ULN",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine < 1 times ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having given written informed consent prior to any procedure related to the study",
            "criterions": [
                {
                    "exact_snippets": "given written informed consent",
                    "criterion": "informed 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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Have other cancer within 5 years",
            "criterions": [
                {
                    "exact_snippets": "Have other cancer within 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Existence of distance metastasis during surgey (M1)",
            "criterions": [
                {
                    "exact_snippets": "Existence of distance metastasis during surgey (M1)",
                    "criterion": "distance metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior malignant tumors with detectable signs of recurrence or distant metastasis",
            "criterions": [
                {
                    "exact_snippets": "Prior malignant tumors",
                    "criterion": "prior malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable signs of recurrence",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled disease e.g. atrial fibrillation",
                    "criterion": "atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poorly controlled disease e.g. ... stenocardia",
                    "criterion": "stenocardia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poorly controlled disease e.g. ... cardiac insufficiency",
                    "criterion": "cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Poorly controlled disease e.g. ... persistent hypertension despite medicinal treatment",
                    "criterion": "persistent hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "ejection fraction<50%",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Epileptic seizures patients need medicine control",
            "criterions": [
                {
                    "exact_snippets": "Epileptic seizures",
                    "criterion": "epileptic seizures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "need medicine control",
                    "criterion": "medicine control",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontroled mental disease or mental disorder",
            "criterions": [
                {
                    "exact_snippets": "Uncontroled mental disease",
                    "criterion": "mental disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontroled ... mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Drug abuse or psychological or social factors affect the judgment of results",
            "criterions": [
                {
                    "exact_snippets": "Drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological or social factors affect the judgment of results",
                    "criterion": "psychological or social factors",
                    "requirements": [
                        {
                            "requirement_type": "impact on judgment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to any therapy contained in this regimen specific to the study",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to any therapy contained in this regimen",
                    "criterion": "contraindication to therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving other chemotherapy, radiotherapy or immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "Receiving other chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving other ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving other ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Without given written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Without given written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Alanine transaminase (ALT) < or = 2.5 times upper limit of nominal (ULN)",
                    "criterion": "Alanine transaminase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}