{
    "info": {
        "nct_id": "NCT00003873",
        "official_title": "Phase III Trial Comparing a 28 Day Schedule of Daily Oral 5-FU Plus Eniluracil to Protracted Intravenous Infusion in Previously Untreated Patients With Advanced Colorectal Cancer",
        "inclusion_criteria": "* Patients with measurable or nonmeasurable histologically confirmed adenocarcinoma of the colon and rectum are eligible provided patient has metastatic, recurrent or residual disease, and tumor is beyond hope of surgical eradication; all pre-study scans documenting disease must be done =< 4 weeks prior to randomization\n\n  * Measurable tumor is defined as a known mass that can be clearly measured in two dimensions by physical examination, CT scan, radionuclide liver scan, or on chest x-ray by a ruler or calipers; the largest diameter of the lesion must measure >= 2 cm by at least one method of evaluation\n* Patients must have had no prior therapy for advanced disease\n* Patients may have had prior adjuvant treatment with 5-FU provided that the last dose was received > 12 months prior to entering the study; no prior chemotherapy other than adjuvant 5-FU is allowed\n* Patients with prior radiotherapy are acceptable, but patients should have measurable or nonmeasurable disease outside the radiation port and/or progressive disease within the previously radiated volume; in addition, it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated\n* Bilirubin =< 1.5 x upper limit of normal (ULN)\n* SGOT =< 3 x ULN\n* Because Eniluracil changes the metabolism of 5-FU such that it is excreted primarily by the kidneys, an estimated creatinine clearance calculated using the Cockcroft and Gault formula must be obtained in patients with a serum creatinine > institutional normal limits; the estimated creatinine clearance must be >= 50 ml/min prior to starting treatment with Eniluracil/5-FU; if not, a measured creatinine clearance must be done (using a 24 hour urine collection); the measured creatinine clearance must be > 50 ml/min for the patient to be eligible\n* Absolute neutrophil count >= 2000 mm³\n* Platelet count >= 100,000 mm³\n* ECOG performance status 0-2\n* No evidence of significant active infection (e.g., pneumonia, peritonitis, wound abscess, etc.) at time of study entry\n* No evidence of serious intercurrent illness such as uncontrolled diabetes mellitus, hypothyroidism, malabsorption syndrome or heart failure\n* No prior neoplastic diseases (within 5 years) aside from the current malignancy or curatively resected melanoma, skin cancer or cervical carcinoma in situ\n* No treatment with folinic acid, interferon, flucytosine or topical 5-FU within the previous 14 days\n* Not pregnant or lactating; pregnant and lactating women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage\n* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with measurable or nonmeasurable histologically confirmed adenocarcinoma of the colon and rectum are eligible provided patient has metastatic, recurrent or residual disease, and tumor is beyond hope of surgical eradication; all pre-study scans documenting disease must be done =< 4 weeks prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "measurable or nonmeasurable histologically confirmed adenocarcinoma of the colon and rectum",
                    "criterion": "adenocarcinoma of the colon and rectum",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "nonmeasurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic, recurrent or residual disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "metastatic",
                                "recurrent",
                                "residual"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor is beyond hope of surgical eradication",
                    "criterion": "tumor surgical eradication potential",
                    "requirements": [
                        {
                            "requirement_type": "eradication potential",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "all pre-study scans documenting disease must be done =< 4 weeks prior to randomization",
                    "criterion": "pre-study scans timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable tumor is defined as a known mass that can be clearly measured in two dimensions by physical examination, CT scan, radionuclide liver scan, or on chest x-ray by a ruler or calipers; the largest diameter of the lesion must measure >= 2 cm by at least one method of evaluation",
            "criterions": [
                {
                    "exact_snippets": "Measurable tumor is defined as a known mass that can be clearly measured in two dimensions",
                    "criterion": "measurable tumor",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "a known mass that can be clearly measured in two dimensions"
                        }
                    ]
                },
                {
                    "exact_snippets": "by physical examination, CT scan, radionuclide liver scan, or on chest x-ray",
                    "criterion": "measurement method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "physical examination",
                                "CT scan",
                                "radionuclide liver scan",
                                "chest x-ray"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "the largest diameter of the lesion must measure >= 2 cm",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have had no prior therapy for advanced disease",
            "criterions": [
                {
                    "exact_snippets": "no prior therapy for advanced disease",
                    "criterion": "prior therapy for advanced disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients may have had prior adjuvant treatment with 5-FU provided that the last dose was received > 12 months prior to entering the study; no prior chemotherapy other than adjuvant 5-FU is allowed",
            "criterions": [
                {
                    "exact_snippets": "Patients may have had prior adjuvant treatment with 5-FU",
                    "criterion": "prior adjuvant treatment with 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the last dose was received > 12 months prior to entering the study",
                    "criterion": "time since last dose of 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no prior chemotherapy other than adjuvant 5-FU is allowed",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with prior radiotherapy are acceptable, but patients should have measurable or nonmeasurable disease outside the radiation port and/or progressive disease within the previously radiated volume; in addition, it must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated",
            "criterions": [
                {
                    "exact_snippets": "prior radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable or nonmeasurable disease outside the radiation port",
                    "criterion": "disease outside the radiation port",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive disease within the previously radiated volume",
                    "criterion": "progressive disease within the previously radiated volume",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 2 weeks since administration of radiation therapy",
                    "criterion": "time since radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "all signs of toxicity must have abated",
                    "criterion": "signs of toxicity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin =< 1.5 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin =< 1.5 x upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT =< 3 x ULN",
            "criterions": [
                {
                    "exact_snippets": "SGOT =< 3 x ULN",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Because Eniluracil changes the metabolism of 5-FU such that it is excreted primarily by the kidneys, an estimated creatinine clearance calculated using the Cockcroft and Gault formula must be obtained in patients with a serum creatinine > institutional normal limits; the estimated creatinine clearance must be >= 50 ml/min prior to starting treatment with Eniluracil/5-FU; if not, a measured creatinine clearance must be done (using a 24 hour urine collection); the measured creatinine clearance must be > 50 ml/min for the patient to be eligible",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine > institutional normal limits",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "institutional normal limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "estimated creatinine clearance ... >= 50 ml/min",
                    "criterion": "estimated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured creatinine clearance ... > 50 ml/min",
                    "criterion": "measured creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count >= 2000 mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count >= 2000 mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >= 100,000 mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >= 100,000 mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 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": "* No evidence of significant active infection (e.g., pneumonia, peritonitis, wound abscess, etc.) at time of study entry",
            "criterions": [
                {
                    "exact_snippets": "No evidence of significant active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pneumonia",
                    "criterion": "pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "peritonitis",
                    "criterion": "peritonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "wound abscess",
                    "criterion": "wound abscess",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of serious intercurrent illness such as uncontrolled diabetes mellitus, hypothyroidism, malabsorption syndrome or heart failure",
            "criterions": [
                {
                    "exact_snippets": "No evidence of serious intercurrent illness such as uncontrolled diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of serious intercurrent illness such as ... hypothyroidism",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of serious intercurrent illness such as ... malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of serious intercurrent illness such as ... heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior neoplastic diseases (within 5 years) aside from the current malignancy or curatively resected melanoma, skin cancer or cervical carcinoma in situ",
            "criterions": [
                {
                    "exact_snippets": "No prior neoplastic diseases (within 5 years)",
                    "criterion": "prior neoplastic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "aside from the current malignancy",
                    "criterion": "current malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively resected melanoma",
                    "criterion": "curatively resected melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively resected ... skin cancer",
                    "criterion": "curatively resected skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively resected ... cervical carcinoma in situ",
                    "criterion": "curatively resected cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No treatment with folinic acid, interferon, flucytosine or topical 5-FU within the previous 14 days",
            "criterions": [
                {
                    "exact_snippets": "No treatment with folinic acid ... within the previous 14 days",
                    "criterion": "folinic acid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No treatment with ... interferon ... within the previous 14 days",
                    "criterion": "interferon treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No treatment with ... flucytosine ... within the previous 14 days",
                    "criterion": "flucytosine treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No treatment with ... topical 5-FU within the previous 14 days",
                    "criterion": "topical 5-FU treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant or lactating; pregnant and lactating women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not ... lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active males",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}