{
    "info": {
        "nct_id": "NCT00193401",
        "official_title": "Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer",
        "inclusion_criteria": "To be included in this study, you must meet the following criteria:\n\n* Biopsy-proven small cell lung cancer, extensive stage disease\n* Age > 65 years\n* No previous chemotherapy or radiation therapy.\n* Measurable or evaluable disease.\n* Adequate bone marrow, liver and kidney function.\n* Must be > 4 weeks from previous major surgery\n* Must give written informed consent prior to study entry.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "You cannot participate in this study if any of the following apply to you:\n\n* Meningeal involvement\n* Serious active infections\n* Serious underlying medical conditions\n* Other active neoplasms\n\nPlease note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Biopsy-proven small cell lung cancer, extensive stage disease",
            "criterions": [
                {
                    "exact_snippets": "Biopsy-proven small cell lung cancer",
                    "criterion": "small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "biopsy-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive stage disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "extensive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age > 65 years",
            "criterions": [
                {
                    "exact_snippets": "Age > 65 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 65,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous chemotherapy or radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "No previous chemotherapy",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... radiation therapy",
                    "criterion": "previous radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or evaluable disease.",
            "criterions": [
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow, liver and kidney function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow ... function.",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver ... function.",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... kidney function.",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be > 4 weeks from previous major surgery",
            "criterions": [
                {
                    "exact_snippets": "Must be > 4 weeks from previous major surgery",
                    "criterion": "time since previous major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must give written informed consent prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Must give 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Meningeal involvement",
            "criterions": [
                {
                    "exact_snippets": "Meningeal involvement",
                    "criterion": "meningeal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious active infections",
            "criterions": [
                {
                    "exact_snippets": "Serious active infections",
                    "criterion": "infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious underlying medical conditions",
            "criterions": [
                {
                    "exact_snippets": "Serious underlying medical conditions",
                    "criterion": "underlying medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other active neoplasms",
            "criterions": [
                {
                    "exact_snippets": "Other active neoplasms",
                    "criterion": "active neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "To be included in this study, you must meet the following criteria:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "You cannot participate in this study if any of the following apply to you:",
            "criterions": []
        },
        {
            "line": "Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}