{
    "info": {
        "nct_id": "NCT01731548",
        "official_title": "Omitting Elective Nodal Irradiation and Irradiating Post-induction Versus Pre-induction Chemotherapy Tumor Extent for Limited-stage Small Cell Lung Cancer",
        "inclusion_criteria": "* Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage\n* Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.\n* The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.\n* Karnofsky performance status was ≥ 80.\n* Forced expiratory volume at 1 second (FEV1) ≥ 1 L.\n* Had measurable or assessable disease.\n* Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.\n* Serum creatine and bilirubin < 1.5 × the upper normal limit (UNL), aminotransferase < 2 × UNL.\n* Weight loss was less than 10% within 6 months before diagnosis.\n* Written informed consent was required from all patients.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients were eligible if they had histologic or cytologic verification of small cell lung cancer (SCLC) and were radiographically confirmed limited-stage",
            "criterions": [
                {
                    "exact_snippets": "histologic or cytologic verification of small cell lung cancer (SCLC)",
                    "criterion": "small cell lung cancer (SCLC)",
                    "requirements": [
                        {
                            "requirement_type": "verification",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographically confirmed limited-stage",
                    "criterion": "limited-stage",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "radiographically"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with contralateral mediastinal and ipsilateral supraclavicular lymphadenopathy were also included.",
            "criterions": [
                {
                    "exact_snippets": "contralateral mediastinal ... lymphadenopathy",
                    "criterion": "contralateral mediastinal lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ipsilateral supraclavicular lymphadenopathy",
                    "criterion": "ipsilateral supraclavicular lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patients should be between 18 and 75 years old without previous thoracic radiotherapy, chemotherapy or biotherapy.",
            "criterions": [
                {
                    "exact_snippets": "patients should be between 18 and 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without previous thoracic radiotherapy",
                    "criterion": "previous thoracic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without previous ... chemotherapy",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without previous ... biotherapy",
                    "criterion": "previous biotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status was ≥ 80.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status was ≥ 80.",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Forced expiratory volume at 1 second (FEV1) ≥ 1 L.",
            "criterions": [
                {
                    "exact_snippets": "Forced expiratory volume at 1 second (FEV1) ≥ 1 L.",
                    "criterion": "forced expiratory volume at 1 second (FEV1)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had measurable or assessable disease.",
            "criterions": [
                {
                    "exact_snippets": "measurable or assessable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "assessable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophilic granulocyte ≥ 1.5×109/L, haemoglobin ≥ 100 g/L, platelet count ≥ 100×109/L.",
            "criterions": [
                {
                    "exact_snippets": "Neutrophilic granulocyte ≥ 1.5×109/L",
                    "criterion": "neutrophilic granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "haemoglobin ≥ 100 g/L",
                    "criterion": "haemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatine and bilirubin < 1.5 × the upper normal limit (UNL), aminotransferase < 2 × UNL.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatine ... < 1.5 × the upper normal limit (UNL)",
                    "criterion": "serum creatine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "× UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin < 1.5 × the upper normal limit (UNL)",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "× UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aminotransferase < 2 × UNL",
                    "criterion": "aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "× UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Weight loss was less than 10% within 6 months before diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "Weight loss was less than 10% within 6 months before diagnosis.",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent was required from all patients.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent was required",
                    "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients were ineligible if they had a history of other malignant diseases except for non-melanomatous skin cancer and carcinoma in situ of the cervix, or any contraindications for chemoradiotherapy, malignant pleural and/or pericardial effusion.",
            "criterions": [
                {
                    "exact_snippets": "history of other malignant diseases",
                    "criterion": "history of other malignant diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications for chemoradiotherapy",
                    "criterion": "contraindications for chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant pleural and/or pericardial effusion",
                    "criterion": "malignant pleural and/or pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}