{
    "info": {
        "nct_id": "NCT00274872",
        "official_title": "Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically proven adenocarcinoma of the colon or rectum\n\n  * Metastatic disease\n\n    * No metastases involving only the bone\n* Inoperable disease (i.e., not suitable for complete surgical resection)\n* Measurable or evaluable disease\n\n  * Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan\n* No symptomatic ascites or pleural effusion that has not been evacuated\n* No CNS metastasis\n\nPATIENT CHARACTERISTICS:\n\n* WHO OR ECOG performance status 0-2\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelets ≥ 100,000/mm^3\n* Creatinine < 3 times upper limit of normal (ULN)\n* Alkaline phosphatase < 5 times ULN\n* No peripheral neuropathy ≥ grade 1\n* No total or partial bowel obstruction\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No uncontrolled hypercalcemia\n* No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years\n* No uncontrolled congestive heart failure\n* No angina pectoris\n* No hypertension\n* No arrhythmias\n* No history of significant neurologic or psychiatric disorders\n* No active infection\n* No other serious nonmalignant disease\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy and/or immunotherapy for metastatic disease\n* Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months\n* No other concurrent anticancer treatment\n* No participation in another clinical trial with any investigational drug within 30 days prior to randomization\n* No other concurrent investigational treatment\n* No concurrent radiotherapy\n* No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis"
    },
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                            "expected_value": "healthy"
                        }
                    }
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            },
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                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
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                                "value": 80,
                                "unit": "Years"
                            }
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                ]
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                        "exact_snippets": "maximum age of 80 Years",
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                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    }
                ]
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        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
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                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "DISEASE CHARACTERISTICS",
                        "criterion": "disease characteristics",
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                            "expected_value": "N/A"
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        },
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                        "exact_snippets": "Metastatic disease",
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                        "exact_snippets": "Inoperable disease (i.e., not suitable for complete surgical resection)",
                        "criterion": "disease operability",
                        "requirement": {
                            "requirement_type": "suitability for surgical resection",
                            "expected_value": false
                        }
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                ]
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                        }
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                ]
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        },
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                "criterions": [
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                        "exact_snippets": "Measurable disease defined as ≥ 1 unidimensionally measurable lesion",
                        "criterion": "measurable disease",
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                            "expected_value": "≥ 1 unidimensionally measurable lesion"
                        }
                    },
                    {
                        "exact_snippets": "≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan",
                        "criterion": "unidimensionally measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
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                                "value": 1,
                                "unit": "lesion"
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                        }
                    },
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                        "criterion": "unidimensionally measurable lesion",
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                            "expected_value": {
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                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan",
                        "criterion": "unidimensionally measurable lesion",
                        "requirement": {
                            "requirement_type": "measurement method",
                            "expected_value": "conventional CT scan"
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                    },
                    {
                        "exact_snippets": "≥ 1 unidimensionally measurable lesion ... ≥ 10 mm by spiral CT scan",
                        "criterion": "unidimensionally measurable lesion",
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                                "unit": "lesion"
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                        }
                    },
                    {
                        "exact_snippets": "≥ 1 unidimensionally measurable lesion ... ≥ 10 mm by spiral CT scan",
                        "criterion": "unidimensionally measurable lesion",
                        "requirement": {
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                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≥ 1 unidimensionally measurable lesion ... ≥ 10 mm by spiral CT scan",
                        "criterion": "unidimensionally measurable lesion",
                        "requirement": {
                            "requirement_type": "measurement method",
                            "expected_value": "spiral CT scan"
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Measurable disease defined as ≥ 1 unidimensionally measurable lesion",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "definition",
                                    "expected_value": "≥ 1 unidimensionally measurable lesion"
                                }
                            },
                            {
                                "exact_snippets": "≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan",
                                "criterion": "unidimensionally measurable lesion",
                                "requirement": {
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                                    "expected_value": {
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                                        "value": 1,
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                                    }
                                }
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                            {
                                "exact_snippets": "≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan",
                                "criterion": "unidimensionally measurable lesion",
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                                        "value": 20,
                                        "unit": "mm"
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                            {
                                "exact_snippets": "≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan",
                                "criterion": "unidimensionally measurable lesion",
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                                    "expected_value": "conventional CT scan"
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                                "exact_snippets": "≥ 1 unidimensionally measurable lesion ... ≥ 10 mm by spiral CT scan",
                                "criterion": "unidimensionally measurable lesion",
                                "requirement": {
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                                        "value": 1,
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        {
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                    {
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                        }
                    }
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                ]
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        },
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                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    },
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                        "criterion": "contraception use",
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                            "requirement_type": "necessity",
                            "expected_value": true
                        }
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                ]
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            "logical_structure": {
                "condition": {
                    "exact_snippets": "Fertile patients",
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                "then_criteria": {
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                    "criterion": "contraception use",
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                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
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                        "exact_snippets": "uncontrolled hypercalcemia",
                        "criterion": "hypercalcemia",
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                            "requirement_type": "control",
                            "expected_value": true
                        }
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                ]
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                    }
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            }
        },
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                "criterions": [
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                        "exact_snippets": "No other concurrent or prior malignancy",
                        "criterion": "other malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except adequately treated carcinoma in situ of the uterine cervix",
                        "criterion": "carcinoma in situ of the uterine cervix",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
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                    {
                        "exact_snippets": "except ... basal or squamous cell carcinoma of the skin",
                        "criterion": "basal or squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
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                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
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                        }
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                                    "exact_snippets": "No other concurrent or prior malignancy",
                                    "criterion": "other malignancy",
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                                        "requirement_type": "presence",
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                                    }
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                                        "exact_snippets": "except adequately treated carcinoma in situ of the uterine cervix",
                                        "criterion": "carcinoma in situ of the uterine cervix",
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                                            "requirement_type": "treatment status",
                                            "expected_value": "adequately treated"
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                                        "exact_snippets": "except ... basal or squamous cell carcinoma of the skin",
                                        "criterion": "basal or squamous cell carcinoma of the skin",
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                ]
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        },
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                        "exact_snippets": "No uncontrolled congestive heart failure",
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                ]
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                }
            }
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        {
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                        "criterion": "arrhythmias",
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                        }
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                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "PRIOR CONCURRENT THERAPY:",
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                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
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                        "exact_snippets": "PRIOR CONCURRENT THERAPY",
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        {
            "identified_line": {
                "line": "* No prior chemotherapy and/or immunotherapy for metastatic disease",
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                        }
                    },
                    {
                        "exact_snippets": "No prior ... immunotherapy for metastatic disease",
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                                "exact_snippets": "No prior chemotherapy ... for metastatic disease",
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                                "requirement": {
                                    "requirement_type": "presence",
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                                }
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                            {
                                "exact_snippets": "No prior ... immunotherapy for metastatic disease",
                                "criterion": "prior immunotherapy for metastatic disease",
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                                    "requirement_type": "presence",
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                                }
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                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is > 6 months",
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                    {
                        "exact_snippets": "Prior adjuvant chemotherapy allowed",
                        "criterion": "prior adjuvant chemotherapy",
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                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progression-free interval after completion of adjuvant chemotherapy is > 6 months",
                        "criterion": "progression-free interval after completion of adjuvant chemotherapy",
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                            "requirement_type": "duration",
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                                "operator": ">",
                                "value": 6,
                                "unit": "months"
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                        }
                    }
                ]
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            "logical_structure": {
                "condition": {
                    "exact_snippets": "Prior adjuvant chemotherapy allowed",
                    "criterion": "prior adjuvant chemotherapy",
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                    }
                },
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                    "exact_snippets": "progression-free interval after completion of adjuvant chemotherapy is > 6 months",
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                            "operator": ">",
                            "value": 6,
                            "unit": "months"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* No other concurrent anticancer treatment",
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                    {
                        "exact_snippets": "No other concurrent anticancer treatment",
                        "criterion": "concurrent anticancer treatment",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No other concurrent anticancer treatment",
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                        "requirement_type": "presence",
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            }
        },
        {
            "identified_line": {
                "line": "* No participation in another clinical trial with any investigational drug within 30 days prior to randomization",
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                    {
                        "exact_snippets": "No participation in another clinical trial with any investigational drug within 30 days prior to randomization",
                        "criterion": "participation in another clinical trial",
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                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                    "exact_snippets": "No participation in another clinical trial with any investigational drug within 30 days prior to randomization",
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                        "requirement_type": "time since last participation",
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                            "operator": ">=",
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                }
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            "identified_line": {
                "line": "* No other concurrent investigational treatment",
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                    {
                        "exact_snippets": "No other concurrent investigational treatment",
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                            "requirement_type": "presence",
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                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No other concurrent investigational treatment",
                        "criterion": "concurrent investigational treatment",
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                            "requirement_type": "presence",
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        },
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            "identified_line": {
                "line": "* No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitis",
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                    {
                        "exact_snippets": "No concurrent cold cap for prevention of alopecia",
                        "criterion": "cold cap usage",
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                            "requirement_type": "concurrent usage",
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                    {
                        "exact_snippets": "No concurrent ... iced mouth rinses for prevention of stomatitis",
                        "criterion": "iced mouth rinses usage",
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                            "requirement_type": "concurrent usage",
                            "expected_value": false
                        }
                    }
                ]
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                        "exact_snippets": "No concurrent cold cap for prevention of alopecia",
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                            "requirement_type": "concurrent usage",
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                    {
                        "exact_snippets": "No concurrent ... iced mouth rinses for prevention of stomatitis",
                        "criterion": "iced mouth rinses usage",
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                            "requirement_type": "concurrent usage",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "PATIENT CHARACTERISTICS:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Not pregnant or nursing",
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                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
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                            "requirement_type": "status",
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                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing",
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                            "requirement_type": "status",
                            "expected_value": false
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                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Not pregnant",
                        "criterion": "pregnancy",
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                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not ... nursing",
                        "criterion": "nursing",
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                            "requirement_type": "status",
                            "expected_value": false
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                    }
                ]
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        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
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        {
            "identified_line": {
                "line": "* Histologically proven adenocarcinoma of the colon or rectum",
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                    {
                        "exact_snippets": "Histologically proven adenocarcinoma",
                        "criterion": "adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
                        }
                    },
                    {
                        "exact_snippets": "adenocarcinoma of the colon or rectum",
                        "criterion": "location of adenocarcinoma",
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                            "requirement_type": "location",
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                                "colon",
                                "rectum"
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            "logical_structure": {
                "and_criteria": [
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                        "exact_snippets": "Histologically proven adenocarcinoma",
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                            "requirement_type": "confirmation method",
                            "expected_value": "histologically proven"
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                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "adenocarcinoma of the colon or rectum",
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                                    "expected_value": "colon"
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                                "exact_snippets": "adenocarcinoma of the colon or rectum",
                                "criterion": "location of adenocarcinoma",
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                                    "requirement_type": "location",
                                    "expected_value": "rectum"
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        },
        {
            "identified_line": {
                "line": "* No metastases involving only the bone",
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                    {
                        "exact_snippets": "No metastases involving only the bone",
                        "criterion": "metastases",
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                            "requirement_type": "location",
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                ]
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            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No metastases involving only the bone",
                    "criterion": "metastases",
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                        "requirement_type": "location",
                        "expected_value": "only the bone"
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        },
        {
            "identified_line": {
                "line": "* Measurable or evaluable disease",
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                            "requirement_type": "measurability",
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                                "measurable",
                                "evaluable"
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                        "exact_snippets": "Measurable or evaluable disease",
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                            "requirement_type": "measurability",
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                        "exact_snippets": "Measurable or evaluable disease",
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                            "requirement_type": "measurability",
                            "expected_value": "evaluable"
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        },
        {
            "identified_line": {
                "line": "* WHO OR ECOG performance status 0-2",
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                        "exact_snippets": "WHO OR ECOG performance status 0-2",
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                            "requirement_type": "scale",
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                                "ECOG"
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                        "exact_snippets": "WHO OR ECOG performance status 0-2",
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                            "requirement_type": "range",
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                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
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                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
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                ]
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            "logical_structure": {
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                        "and_criteria": [
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                                "exact_snippets": "WHO OR ECOG performance status 0-2",
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                                "requirement": {
                                    "requirement_type": "scale",
                                    "expected_value": "WHO"
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                                "exact_snippets": "WHO OR ECOG performance status 0-2",
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                                                "operator": ">=",
                                                "value": 0,
                                                "unit": "N/A"
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                                            {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "N/A"
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                        "and_criteria": [
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                                "exact_snippets": "WHO OR ECOG performance status 0-2",
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                                "exact_snippets": "WHO OR ECOG performance status 0-2",
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                                                "operator": ">=",
                                                "value": 0,
                                                "unit": "N/A"
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                                            {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "N/A"
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                            }
                        ]
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        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count ≥ 1,500/mm^3",
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                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
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                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
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                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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        {
            "identified_line": {
                "line": "* Platelets ≥ 100,000/mm^3",
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                            "requirement_type": "quantity",
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                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
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                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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            "identified_line": {
                "line": "* Creatinine < 3 times upper limit of normal (ULN)",
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                    {
                        "exact_snippets": "Creatinine < 3 times upper limit of normal (ULN)",
                        "criterion": "creatinine level",
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                            "requirement_type": "quantity",
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                                "operator": "<",
                                "value": 3,
                                "unit": "times ULN"
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                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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        {
            "identified_line": {
                "line": "* Alkaline phosphatase < 5 times ULN",
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                    {
                        "exact_snippets": "Alkaline phosphatase < 5 times ULN",
                        "criterion": "alkaline phosphatase",
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                            "requirement_type": "level",
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                                "operator": "<",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
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                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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        },
        {
            "identified_line": {
                "line": "* No peripheral neuropathy ≥ grade 1",
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                    {
                        "exact_snippets": "No peripheral neuropathy ≥ grade 1",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "grade"
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                        }
                    }
                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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        {
            "identified_line": {
                "line": "* No total or partial bowel obstruction",
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                    {
                        "exact_snippets": "No total or partial bowel obstruction",
                        "criterion": "bowel obstruction",
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                            "requirement_type": "presence",
                            "expected_value": false
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                ]
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            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
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                    "requirement_type": "failed",
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            }
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        {
            "identified_line": {
                "line": "* No angina pectoris",
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                    {
                        "exact_snippets": "No angina pectoris",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
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            "logical_structure": {
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                    "exact_snippets": "No angina pectoris",
                    "criterion": "angina pectoris",
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                        "requirement_type": "presence",
                        "expected_value": true
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        },
        {
            "identified_line": {
                "line": "* No hypertension",
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                    {
                        "exact_snippets": "No hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
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                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No hypertension",
                    "criterion": "hypertension",
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                        "requirement_type": "presence",
                        "expected_value": true
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                }
            }
        },
        {
            "identified_line": {
                "line": "* No concurrent radiotherapy",
                "criterions": [
                    {
                        "exact_snippets": "No concurrent radiotherapy",
                        "criterion": "concurrent radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "No concurrent radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ]
}