{
    "info": {
        "nct_id": "NCT00872482",
        "official_title": "A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* Providing a written informed consent (see Appendix A);\n* Age ≥18 years;\n* Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other);\n* At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;\n* Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration\n* KPS ≥70;\n* Absolute neutrophil count ≥ 1500/mm³;\n* Platelet count ≥ 50,000/mm³;\n* Serum creatinine ≤2.0 mg/dL;\n* Serum transaminases ≤2 x the upper limit of normal (ULN);\n* Total serum bilirubin ≤2 x ULN;\n* And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception);\n* Prior WBRT, brain metastases resection with no other measurable lesion remaining;\n* Extracranial metastases in two or more organs;\n* Known leptomeningeal or subarachnoid tumor spread;\n* Plan to use radiosurgery or radiation boost after completion of WBRT;\n* Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;\n* Previous use of an anti-EGFR drug;\n* Participation in another ongoing therapeutic trial;\n* Presence of known HIV seropositivity, severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix);\n* Hypersensitivity or allergy to any of the drugs to be administered in this study;\n* Inability or unwillingness to complete the required assessments;\n* Geographic inaccessibility for treatment or follow-up evaluations.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Providing a written informed consent (see Appendix A);",
            "criterions": [
                {
                    "exact_snippets": "Providing a written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other);",
            "criterions": [
                {
                    "exact_snippets": "Histologic or cytologic confirmed diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other)",
                    "criterion": "NSCLC epithelial type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "squamous",
                                "adenocarcinoma",
                                "large cell",
                                "other"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed measurable metastatic lesion from NSCLC in the brain",
                    "criterion": "metastatic lesion in the brain from NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration",
            "criterions": [
                {
                    "exact_snippets": "initial diagnosis of brain metastases by image",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "image"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 8 weeks of registration",
                    "criterion": "time since diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KPS ≥70;",
            "criterions": [
                {
                    "exact_snippets": "KPS ≥70",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1500/mm³;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1500/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 50,000/mm³;",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 50,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine ≤2.0 mg/dL;",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ≤2.0 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum transaminases ≤2 x the upper limit of normal (ULN);",
            "criterions": [
                {
                    "exact_snippets": "Serum transaminases ≤2 x the upper limit of normal (ULN);",
                    "criterion": "serum transaminases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total serum bilirubin ≤2 x ULN;",
            "criterions": [
                {
                    "exact_snippets": "Total serum bilirubin ≤2 x ULN",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "lactate dehydrogenase (LDH) level ≤1.3 x ULN",
                    "criterion": "lactate dehydrogenase (LDH) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception);",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "parturition within the previous 30 days",
                    "criterion": "recent parturition",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fertile female or male patients should practice contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior WBRT, brain metastases resection with no other measurable lesion remaining;",
            "criterions": [
                {
                    "exact_snippets": "Prior WBRT",
                    "criterion": "whole brain radiotherapy (WBRT)",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases resection",
                    "criterion": "brain metastases resection",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no other measurable lesion remaining",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Extracranial metastases in two or more organs;",
            "criterions": [
                {
                    "exact_snippets": "Extracranial metastases in two or more organs",
                    "criterion": "extracranial metastases",
                    "requirements": [
                        {
                            "requirement_type": "number of organs affected",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "organs"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known leptomeningeal or subarachnoid tumor spread;",
            "criterions": [
                {
                    "exact_snippets": "Known leptomeningeal ... tumor spread",
                    "criterion": "leptomeningeal tumor spread",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known ... subarachnoid tumor spread",
                    "criterion": "subarachnoid tumor spread",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plan to use radiosurgery or radiation boost after completion of WBRT;",
            "criterions": [
                {
                    "exact_snippets": "Plan to use radiosurgery",
                    "criterion": "radiosurgery",
                    "requirements": [
                        {
                            "requirement_type": "planned usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation boost after completion of WBRT",
                    "criterion": "radiation boost",
                    "requirements": [
                        {
                            "requirement_type": "planned usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;",
            "criterions": [
                {
                    "exact_snippets": "use chemotherapy or any other systemic antineoplastic modality during WBRT",
                    "criterion": "use of systemic antineoplastic modality during WBRT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous use of an anti-EGFR drug;",
            "criterions": [
                {
                    "exact_snippets": "Previous use of an anti-EGFR drug",
                    "criterion": "anti-EGFR drug use",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in another ongoing therapeutic trial;",
            "criterions": [
                {
                    "exact_snippets": "Participation in another ongoing therapeutic trial",
                    "criterion": "participation in another therapeutic trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ongoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of known HIV seropositivity, severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix);",
            "criterions": [
                {
                    "exact_snippets": "Presence of known HIV seropositivity",
                    "criterion": "HIV seropositivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe comorbidities",
                    "criterion": "severe comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignant neoplasm within 5 years",
                    "criterion": "malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypersensitivity or allergy to any of the drugs to be administered in this study;",
            "criterions": [
                {
                    "exact_snippets": "Hypersensitivity or allergy to any of the drugs to be administered in this study",
                    "criterion": "hypersensitivity or allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to complete the required assessments;",
            "criterions": [
                {
                    "exact_snippets": "Inability or unwillingness to complete the required assessments",
                    "criterion": "ability and willingness to complete assessments",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Geographic inaccessibility for treatment or follow-up evaluations.",
            "criterions": [
                {
                    "exact_snippets": "Geographic inaccessibility for treatment or follow-up evaluations.",
                    "criterion": "geographic accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}