{
    "info": {
        "nct_id": "NCT00003062",
        "official_title": "A Phase II Study of TEMOZOLOMIDE in Advanced Non-Small Cell Lung Cancer With and Without Brain Metastases",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have maximum age of 69 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed progressive or recurrent stage IV non-small cell lung cancer (NSCLC) Patient with brain metastases on CT or MRI scan are included Symptomatic cases must have had brain radiotherapy at least one month prior to registration Patients without brain metastases: At least one target lesion Bidimensionally measurable Not previously irradiated\n\nPATIENT CHARACTERISTICS: Age: Under 70 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.46 mg/dL Transaminases less than 2 times upper limit of normal Renal: Creatinine no greater than 1.70 mg/dL Creatinine clearance greater than 60 mL/min Other: No prior or concurrent malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin Not pregnant or nursing Negative pregnancy test 24 hours prior to commencing temozolomide\n\nPRIOR CONCURRENT THERAPY: No other investigational drugs allowed during this study Biologic therapy: Prior biologic therapy allowed No concurrent biologic therapy allowed No concurrent growth factor to induce neutrophil increase No concurrent erythropoietin Chemotherapy: No prior chemotherapy for metastatic disease At least 3 months since any neoadjuvant and adjuvant treatment, and induction chemotherapy preceding radical radiotherapy Endocrine therapy: See Protocol Outline Concurrent steroids should be maintained on the lowest dose possible Radiotherapy: Prior radiotherapy allowed Concurrent local radiotherapy to nonbrain lesions allowed Concurrent palliative radiation therapy of bone lesions permitted No concurrent radiation to target lesions No concurrent brain radiotherapy Surgery: Prior surgery allowed"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 69 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 69 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 69,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically confirmed progressive or recurrent stage IV non-small cell lung cancer (NSCLC) Patient with brain metastases on CT or MRI scan are included Symptomatic cases must have had brain radiotherapy at least one month prior to registration Patients without brain metastases: At least one target lesion Bidimensionally measurable Not previously irradiated",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed progressive or recurrent stage IV non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": "progressive or recurrent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient with brain metastases on CT or MRI scan",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "detection",
                            "expected_value": "on CT or MRI scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptomatic cases must have had brain radiotherapy at least one month prior to registration",
                    "criterion": "brain radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at least one month prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients without brain metastases: At least one target lesion",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Bidimensionally measurable",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "bidimensionally measurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Not previously irradiated",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "irradiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: No other investigational drugs allowed during this study Biologic therapy: Prior biologic therapy allowed No concurrent biologic therapy allowed No concurrent growth factor to induce neutrophil increase No concurrent erythropoietin Chemotherapy: No prior chemotherapy for metastatic disease At least 3 months since any neoadjuvant and adjuvant treatment, and induction chemotherapy preceding radical radiotherapy Endocrine therapy: See Protocol Outline Concurrent steroids should be maintained on the lowest dose possible Radiotherapy: Prior radiotherapy allowed Concurrent local radiotherapy to nonbrain lesions allowed Concurrent palliative radiation therapy of bone lesions permitted No concurrent radiation to target lesions No concurrent brain radiotherapy Surgery: Prior surgery allowed",
            "criterions": [
                {
                    "exact_snippets": "No other investigational drugs allowed during this study",
                    "criterion": "concurrent investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior biologic therapy allowed",
                    "criterion": "prior biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent biologic therapy allowed",
                    "criterion": "concurrent biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent growth factor to induce neutrophil increase",
                    "criterion": "concurrent growth factor to induce neutrophil increase",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent erythropoietin",
                    "criterion": "concurrent erythropoietin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior chemotherapy for metastatic disease",
                    "criterion": "prior chemotherapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 3 months since any neoadjuvant and adjuvant treatment, and induction chemotherapy preceding radical radiotherapy",
                    "criterion": "time since neoadjuvant and adjuvant treatment, and induction chemotherapy preceding radical radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent steroids should be maintained on the lowest dose possible",
                    "criterion": "concurrent steroids",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "lowest possible"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior radiotherapy allowed",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent local radiotherapy to nonbrain lesions allowed",
                    "criterion": "concurrent local radiotherapy to nonbrain lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent palliative radiation therapy of bone lesions permitted",
                    "criterion": "concurrent palliative radiation therapy of bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent radiation to target lesions",
                    "criterion": "concurrent radiation to target lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent brain radiotherapy",
                    "criterion": "concurrent brain radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior surgery allowed",
                    "criterion": "prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS: Age: Under 70 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.46 mg/dL Transaminases less than 2 times upper limit of normal Renal: Creatinine no greater than 1.70 mg/dL Creatinine clearance greater than 60 mL/min Other: No prior or concurrent malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin Not pregnant or nursing Negative pregnancy test 24 hours prior to commencing temozolomide",
            "criterions": [
                {
                    "exact_snippets": "Age: Under 70",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: WHO 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "WHO"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "WHO"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: Not specified",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Absolute neutrophil count greater than 2,000/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 2000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: ... WBC greater than 3,500/mm3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 3500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: ... Platelet count greater than 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 1.46 mg/dL",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.46,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: ... Transaminases less than 2 times upper limit of normal",
                    "criterion": "transaminases",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 1.70 mg/dL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.7,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: ... Creatinine clearance greater than 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No prior or concurrent malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin",
                    "criterion": "prior or concurrent malignancies",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: Not pregnant or nursing",
                    "criterion": "pregnancy or nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant or nursing"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: Negative pregnancy test 24 hours prior to commencing temozolomide",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        }
    ]
}