{
    "info": {
        "nct_id": "NCT02454673",
        "official_title": "Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures",
        "inclusion_criteria": "* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer\n* Age ≥18 years old\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1\n* Body mass index ≥ 18\n* No prior chemotherapy or chemoradiotherapy\n* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)\n* No evidence of metastasis (M0)\n* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated\n* Patients with evidence of severe or uncontrolled systemic disease\n* Medically unfit for chemotherapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the stomach",
                    "criterion": "adenocarcinoma of the stomach",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of ... gastroesophageal cancer",
                    "criterion": "gastroesophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1",
            "criterions": [
                {
                    "exact_snippets": "Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1",
                    "criterion": "Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Eastern Cooperative Oncology Group (ECOG)"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body mass index ≥ 18",
            "criterions": [
                {
                    "exact_snippets": "Body mass index ≥ 18",
                    "criterion": "body mass index",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy or chemoradiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... chemoradiotherapy",
                    "criterion": "prior chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)",
            "criterions": [
                {
                    "exact_snippets": "TNM stage of T3-T4",
                    "criterion": "TNM stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "positive regional lymph nodes (N+)",
                    "criterion": "regional lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "endoscopic ultrasound or computed tomography (CT)",
                    "criterion": "diagnostic method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "endoscopic ultrasound",
                                "computed tomography"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of metastasis (M0)",
            "criterions": [
                {
                    "exact_snippets": "No evidence of metastasis (M0)",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematological ... functions",
                    "criterion": "hematological functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver ... functions",
                    "criterion": "liver functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal functions",
                    "criterion": "renal functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT ... ≤2.5 UNL",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST≤2.5 UNL",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤1.5 UNL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ≤1.5 UNL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated",
            "criterions": [
                {
                    "exact_snippets": "previous (less than 10 years) or current history of malignant neoplasms",
                    "criterion": "history of malignant neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "current presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated",
                    "criterion": "curative treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with evidence of severe or uncontrolled systemic disease",
            "criterions": [
                {
                    "exact_snippets": "evidence of severe or uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically unfit for chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Medically unfit for chemotherapy",
                    "criterion": "fitness for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}