{
    "info": {
        "nct_id": "NCT00003594",
        "official_title": "A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy\n\n  * Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:\n\n    * More than 5 years has elapsed since primary surgery OR\n    * Primary cancer was stage I or II\n* Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel\n* Measurable or evaluable disease\n* No CNS metastases or carcinomatous meningitis\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 12 weeks\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm^3\n* Platelet count at least 100,000/mm^3\n* Hemoglobin at least 9.0 g/dL (transfusion allowed)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* AST no greater than 5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No uncontrolled hypertension\n* No unstable angina\n* No symptomatic congestive heart failure\n* No myocardial infarction within the past 6 months\n* No serious uncontrolled arrhythmia\n* No New York Heart Association class III or IV cardiac disease\n\nPulmonary:\n\n* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\n* No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active or uncontrolled infection\n* No symptomatic sensory peripheral neuropathy\n* No known allergy to platinum compounds\n* No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician\n* No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis\n* No medical or psychiatric conditions that would preclude study\n* No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day\n* Colostomy or ileostomy allowed at investigator's discretion\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease\n* No concurrent sargramostim (GM-CSF)\n\nChemotherapy:\n\n* No prior chemotherapy for advanced colorectal cancer\n* No prior standard adjuvant chemotherapy for rectal cancer\n* Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)\n* No prior radiotherapy to more than 15% of bone marrow\n* No prior standard adjuvant radiotherapy for rectal cancer\n\nSurgery:\n\n* See Disease Characteristics\n* At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered\n* Insertion of a vascular access device not considered major or minor surgery\n\nOther:\n\n* No other concurrent investigational agents"
    },
    "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 or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "colorectal adenocarcinoma confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma",
                    "criterion": "colorectal adenocarcinoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "locally recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not curable by surgery or radiotherapy",
                    "criterion": "curability by surgery or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological requirement waived",
                    "criterion": "histological or cytological requirement",
                    "requirements": [
                        {
                            "requirement_type": "waived",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who developed radiological or clinical evidence of metastatic cancer",
                    "criterion": "metastatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "radiological",
                                "clinical"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 5 years has elapsed since primary surgery OR",
            "criterions": [
                {
                    "exact_snippets": "More than 5 years has elapsed since primary surgery",
                    "criterion": "time since primary surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary cancer was stage I or II",
            "criterions": [
                {
                    "exact_snippets": "Primary cancer was stage I or II",
                    "criterion": "primary cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel",
            "criterions": [
                {
                    "exact_snippets": "Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically",
                    "criterion": "site of primary lesion",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "endoscopically",
                                "radiologically",
                                "surgically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Site of primary lesion ... to be or have been in the large bowel",
                    "criterion": "site of primary lesion",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "large bowel"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or evaluable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No CNS metastases or carcinomatous meningitis",
            "criterions": [
                {
                    "exact_snippets": "No CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "At least 12 weeks",
                    "criterion": "duration",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic:",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic:",
                    "criterion": "hematopoietic system",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute granulocyte count at least 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocyte count at least 1,500/mm^3",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "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": "* Hemoglobin at least 9.0 g/dL (transfusion allowed)",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin at least 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "transfusion allowed",
                    "criterion": "transfusion",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic:",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin no greater than 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin no greater than 1.5 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST no greater than 5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "AST no greater than 5 times upper limit of normal (ULN)",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase no greater than 5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase no greater than 5 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "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 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular:",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular:",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "No uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable angina",
            "criterions": [
                {
                    "exact_snippets": "No unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No myocardial infarction within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "No myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious uncontrolled arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "No serious uncontrolled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III or IV cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III or IV cardiac disease",
                    "criterion": "New York Heart Association cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pulmonary:",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary:",
                    "criterion": "pulmonary condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung",
            "criterions": [
                {
                    "exact_snippets": "No interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... extensive and symptomatic interstitial fibrosis of the lung",
                    "criterion": "interstitial fibrosis of the lung",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "extent",
                            "expected_value": "not extensive"
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)",
            "criterions": [
                {
                    "exact_snippets": "No pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... ascites that cause respiratory compromise",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not causing respiratory compromise"
                        }
                    ]
                },
                {
                    "exact_snippets": "No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)",
                    "criterion": "dyspnea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "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 active or uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "No active or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "not active",
                                "controlled"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic sensory peripheral neuropathy",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic sensory peripheral neuropathy",
                    "criterion": "sensory peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known allergy to platinum compounds",
            "criterions": [
                {
                    "exact_snippets": "No known allergy to platinum compounds",
                    "criterion": "allergy to platinum compounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician",
            "criterions": [
                {
                    "exact_snippets": "No history of gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis",
            "criterions": [
                {
                    "exact_snippets": "No other prior or concurrent malignancy within the past 3 years",
                    "criterion": "prior or concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the uterine cervix",
                    "criterion": "carcinoma in situ of the uterine cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis",
                    "criterion": "resected malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "probability of tumor relapse",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 10,
                                        "unit": "%"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No medical or psychiatric conditions that would preclude study",
            "criterions": [
                {
                    "exact_snippets": "No medical ... conditions that would preclude study",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... psychiatric conditions that would preclude study",
                    "criterion": "psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day",
            "criterions": [
                {
                    "exact_snippets": "No colonic or small bowel disorders",
                    "criterion": "colonic or small bowel disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled symptoms of more than 3 loose stools per day",
                    "criterion": "loose stools per day",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "stools per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Colostomy or ileostomy allowed at investigator's discretion",
            "criterions": [
                {
                    "exact_snippets": "Colostomy or ileostomy allowed",
                    "criterion": "colostomy or ileostomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant immunotherapy for resected stage II-IV disease allowed",
                    "criterion": "prior adjuvant immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III",
                                "IV"
                            ]
                        },
                        {
                            "requirement_type": "resection",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant therapy concluded at least 1 year before documentation of recurrent disease",
                    "criterion": "adjuvant therapy conclusion",
                    "requirements": [
                        {
                            "requirement_type": "time before recurrent disease",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent sargramostim (GM-CSF)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent sargramostim (GM-CSF)",
                    "criterion": "sargramostim (GM-CSF)",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy:",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy for advanced colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy for advanced colorectal cancer",
                    "criterion": "prior chemotherapy for advanced colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior standard adjuvant chemotherapy for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior standard adjuvant chemotherapy for rectal cancer",
                    "criterion": "prior standard adjuvant chemotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease",
            "criterions": [
                {
                    "exact_snippets": "Prior adjuvant fluorouracil for resected stage II-IV disease allowed",
                    "criterion": "prior adjuvant fluorouracil",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant therapy concluded at least 1 year before documentation of recurrent disease",
                    "criterion": "time since adjuvant therapy conclusion",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior major radiotherapy",
                    "criterion": "time since prior major radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to more than 15% of bone marrow",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to more than 15% of bone marrow",
                    "criterion": "prior radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "% of bone marrow"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior standard adjuvant radiotherapy for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior standard adjuvant radiotherapy for rectal cancer",
                    "criterion": "prior standard adjuvant radiotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery:",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "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 details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks since prior major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "2 weeks for minor surgery",
                    "criterion": "time since minor surgery",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Insertion of a vascular access device not considered major or minor surgery",
            "criterions": [
                {
                    "exact_snippets": "Insertion of a vascular access device",
                    "criterion": "vascular access device insertion",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "not considered major or minor surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational agents",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational agents",
                    "criterion": "concurrent investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "Other:",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other:",
            "criterions": []
        }
    ]
}