{
    "info": {
        "nct_id": "NCT00502762",
        "official_title": "Salvage Treatment With Topotecan in Patients With Irinotecan-Refractory Small Cell Lung Cancer",
        "inclusion_criteria": "* histologically or cytologically proven SCLC\n* refractory to prior irinotecan-based chemotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* age between 18 and 75 years\n* no active brain or leptomeningeal metastases\n* adequate hematologic, hepatic and renal functions\n* at least one measurable lesion(s)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* pregnant or lactating women\n* patients with active infection\n* extensive radiotherapy within the previous 4 weeks\n* previous other malignancies with the exception of adequately treated non-melanoma skin cancer or in situ cervical cancer\n* any severe comorbid illness\n* a known history of anaphylaxis of any origin\n* history of severe adverse events to the drug used in this study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* histologically or cytologically proven SCLC",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically proven SCLC",
                        "criterion": "SCLC",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically or cytologically proven SCLC",
                        "criterion": "SCLC",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* refractory to prior irinotecan-based chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "refractory to prior irinotecan-based chemotherapy",
                        "criterion": "irinotecan-based chemotherapy",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "refractory to prior irinotecan-based chemotherapy",
                        "criterion": "irinotecan-based chemotherapy",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status ≤2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* age between 18 and 75 years",
                "criterions": [
                    {
                        "exact_snippets": "age between 18 and 75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "age between 18 and 75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* no active brain or leptomeningeal metastases",
                "criterions": [
                    {
                        "exact_snippets": "no active brain ... metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no active ... leptomeningeal metastases",
                        "criterion": "leptomeningeal metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no active brain ... metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "no active ... leptomeningeal metastases",
                        "criterion": "leptomeningeal metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* adequate hematologic, hepatic and renal functions",
                "criterions": [
                    {
                        "exact_snippets": "adequate hematologic ... functions",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... hepatic ... functions",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... renal functions",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate hematologic ... functions",
                        "criterion": "hematologic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... hepatic ... functions",
                        "criterion": "hepatic function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate ... renal functions",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* at least one measurable lesion(s)",
                "criterions": [
                    {
                        "exact_snippets": "at least one measurable lesion(s)",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "at least one measurable lesion(s)",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* pregnant or lactating women",
                "criterions": [
                    {
                        "exact_snippets": "pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* patients with active infection",
                "criterions": [
                    {
                        "exact_snippets": "patients with active infection",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "patients with active infection",
                    "criterion": "active infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* extensive radiotherapy within the previous 4 weeks",
                "criterions": [
                    {
                        "exact_snippets": "extensive radiotherapy within the previous 4 weeks",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    },
                    {
                        "exact_snippets": "extensive radiotherapy within the previous 4 weeks",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the previous 4 weeks"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "extensive radiotherapy within the previous 4 weeks",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    },
                    {
                        "exact_snippets": "extensive radiotherapy within the previous 4 weeks",
                        "criterion": "radiotherapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the previous 4 weeks"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* previous other malignancies with the exception of adequately treated non-melanoma skin cancer or in situ cervical cancer",
                "criterions": [
                    {
                        "exact_snippets": "previous other malignancies",
                        "criterion": "previous malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequately treated non-melanoma skin cancer",
                        "criterion": "non-melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "in situ cervical cancer",
                        "criterion": "in situ cervical cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "previous other malignancies",
                                    "criterion": "previous malignancies",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "adequately treated non-melanoma skin cancer",
                                    "criterion": "non-melanoma skin cancer",
                                    "requirement": {
                                        "requirement_type": "treatment status",
                                        "expected_value": "adequately treated"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "in situ cervical cancer",
                            "criterion": "in situ cervical cancer",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* any severe comorbid illness",
                "criterions": [
                    {
                        "exact_snippets": "any severe comorbid illness",
                        "criterion": "comorbid illness",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "any severe comorbid illness",
                        "criterion": "comorbid illness",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* a known history of anaphylaxis of any origin",
                "criterions": [
                    {
                        "exact_snippets": "a known history of anaphylaxis of any origin",
                        "criterion": "anaphylaxis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "a known history of anaphylaxis of any origin",
                    "criterion": "anaphylaxis",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* history of severe adverse events to the drug used in this study",
                "criterions": [
                    {
                        "exact_snippets": "history of severe adverse events to the drug used in this study",
                        "criterion": "adverse events to the drug",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of severe adverse events to the drug used in this study",
                        "criterion": "adverse events to the drug",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "history of severe adverse events to the drug used in this study",
                        "criterion": "adverse events to the drug",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of severe adverse events to the drug used in this study",
                        "criterion": "adverse events to the drug",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}