{
    "info": {
        "nct_id": "NCT00006082",
        "official_title": "Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a \"5 Days On - 2 Days Off\" Oral Treatment in Advanced Small Cell Lung Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen\n\n  * Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression OR\n  * Refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy\n* Minimum of 1 target lesion that can be accurately measured in at least 1 dimension\n\n  * 20 mm or more with conventional techniques OR\n  * 10 mm or more with spiral CT scans\n* No symptomatic brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Neutrophil count at least 2,000/mm^3\n* Platelet count at least 100,000/mm^3\n\nHepatic:\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)\n\nRenal:\n\n* Creatinine no greater than 1.7 mg/dL\n\nCardiovascular:\n\n* No ischemic heart disease within the past 6 months\n* Normal 12 lead electrocardiogram\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer\n* No unstable systemic disease or active uncontrolled infection\n* No psychological, familial, sociological, or geographical condition that may preclude compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior maintenance therapy with biologic agents following first line chemotherapy allowed\n* No concurrent filgrastim (G-CSF) with nitrocamptothecin\n\nChemotherapy:\n\n* See Disease Characteristics\n* Greater than 4 weeks since prior chemotherapy\n* No more than 1 prior chemotherapy regimen for extensive disease\n* Alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Greater than 4 weeks since prior radiotherapy\n\nSurgery:\n\n* Greater than 2 weeks since prior major surgery\n\nOther:\n\n* No other concurrent anticancer therapy\n* No other concurrent investigational therapy"
    },
    "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 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": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven advanced (extensive stage) small cell lung cancer",
                    "criterion": "small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "extensive"
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive or recurrent disease",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "progressive",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "after 1 first line chemotherapy regimen",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": "1 first line"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression OR",
            "criterions": [
                {
                    "exact_snippets": "Sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months",
                    "criterion": "sensitive disease",
                    "requirements": [
                        {
                            "requirement_type": "response duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Refractory disease, defined as no response to prior chemotherapy",
                    "criterion": "refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "response to prior chemotherapy",
                            "expected_value": "no response"
                        }
                    ]
                },
                {
                    "exact_snippets": "Refractory disease, defined as ... a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy",
                    "criterion": "refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "response to prior chemotherapy",
                            "expected_value": "response followed by progression within 3 months after completion of all prior therapy, including radiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Minimum of 1 target lesion that can be accurately measured in at least 1 dimension",
            "criterions": [
                {
                    "exact_snippets": "Minimum of 1 target lesion",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "accurately measured in at least 1 dimension",
                    "criterion": "target lesion measurement",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "accurately measured in at least 1 dimension"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 20 mm or more with conventional techniques OR",
            "criterions": [
                {
                    "exact_snippets": "20 mm or more with conventional techniques",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 10 mm or more with spiral CT scans",
            "criterions": [
                {
                    "exact_snippets": "10 mm or more with spiral CT scans",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic brain metastases",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age:",
            "criterions": [
                {
                    "exact_snippets": "Age:",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 and over",
            "criterions": [
                {
                    "exact_snippets": "18 and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Performance status:",
            "criterions": [
                {
                    "exact_snippets": "Performance status:",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy:",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 3 months",
            "criterions": [
                {
                    "exact_snippets": "At least 3 months",
                    "criterion": "duration",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neutrophil count at least 2,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count at least 2,000/mm^3",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic:",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than 1.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than 1.5 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ... no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)",
                    "criterion": "Alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level with hepatic metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT ... no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level with hepatic metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGPT no greater than 2.5 time ULN (no greater than 5 times ULN if hepatic metastases present)",
                    "criterion": "SGPT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level with hepatic metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal:",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.7 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.7 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.7,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ischemic heart disease within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No ischemic heart disease within the past 6 months",
                    "criterion": "ischemic heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal 12 lead electrocardiogram",
            "criterions": [
                {
                    "exact_snippets": "Normal 12 lead electrocardiogram",
                    "criterion": "electrocardiogram",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "12 lead"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other prior or concurrent malignancy",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cone biopsied carcinoma of the cervix",
                    "criterion": "cone biopsied carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "adequately treated basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable systemic disease or active uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "No unstable systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "active uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychological, familial, sociological, or geographical condition that may preclude compliance",
            "criterions": [
                {
                    "exact_snippets": "No psychological ... condition that may preclude compliance",
                    "criterion": "psychological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... familial ... condition that may preclude compliance",
                    "criterion": "familial condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... sociological ... condition that may preclude compliance",
                    "criterion": "sociological condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... geographical condition that may preclude compliance",
                    "criterion": "geographical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biologic therapy:",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior maintenance therapy with biologic agents following first line chemotherapy allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior maintenance therapy with biologic agents",
                    "criterion": "maintenance therapy with biologic agents",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "following first line chemotherapy",
                    "criterion": "first line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent filgrastim (G-CSF) with nitrocamptothecin",
            "criterions": [
                {
                    "exact_snippets": "No concurrent filgrastim (G-CSF) with nitrocamptothecin",
                    "criterion": "concurrent filgrastim (G-CSF) use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see disease characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Greater than 4 weeks since prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Greater than 4 weeks since prior chemotherapy",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No more than 1 prior chemotherapy regimen for extensive disease",
            "criterions": [
                {
                    "exact_snippets": "No more than 1 prior chemotherapy regimen for extensive disease",
                    "criterion": "prior chemotherapy regimen for extensive disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy",
            "criterions": [
                {
                    "exact_snippets": "Alternate or sequential use of different regimens without interruption in first line treatment",
                    "criterion": "first line treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": "alternate or sequential"
                        },
                        {
                            "requirement_type": "interruption",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy:",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Greater than 4 weeks since prior radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Greater than 4 weeks since prior radiotherapy",
                    "criterion": "time since prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Greater than 2 weeks since prior major surgery",
            "criterions": [
                {
                    "exact_snippets": "Greater than 2 weeks since prior major surgery",
                    "criterion": "time since prior major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent anticancer therapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent anticancer therapy",
                    "criterion": "concurrent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational therapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational therapy",
                    "criterion": "concurrent investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": []
        }
    ]
}