{
    "info": {
        "nct_id": "NCT00084591",
        "official_title": "Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary adenocarcinoma of the rectum\n\n  * Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam\n  * Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:\n\n    * Physical exam\n    * Transrectal ultrasound\n    * Pelvic CT scan\n    * Pelvic MRI\n* No clinical evidence of metastatic disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm^3\n* Platelet count ≥ 100,000/mm^3\n* No known, uncontrolled coagulopathy\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* SGOT and SGPT ≤ 1.5 times ULN\n* Alkaline phosphatase ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times normal\n* Creatinine clearance > 50 mL/min\n\nCardiovascular\n\n* No clinically significant cardiac disease\n* No congestive heart failure\n* No symptomatic coronary artery disease\n* No poorly controlled cardiac arrhythmias\n* No myocardial infarction within the past year\n\nGastrointestinal\n\n* No active inflammatory bowel disease\n* No lack of physical integrity of the upper gastrointestinal tract\n* No malabsorption syndrome\n\nOther\n\n* No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer\n* No concurrent serious, uncontrolled infection(s)\n* No prior unanticipated severe reaction to fluoropyrimidine therapy\n* No known sensitivity to fluorouracil\n* No prior uncontrolled seizures\n* No CNS disorders that would preclude study participation\n* No other medical or psychiatric condition that would preclude study participation\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior immunotherapy for rectal cancer\n\nChemotherapy\n\n* No prior chemotherapy for rectal cancer\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy for rectal cancer\n* No prior pelvic radiotherapy\n\nSurgery\n\n* More than 4 weeks since prior major surgery and recovered\n* No prior surgery for rectal cancer\n\nOther\n\n* More than 4 weeks since prior participation in another investigational drug study\n* No concurrent celecoxib"
    },
    "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 confirmed primary adenocarcinoma of the rectum",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed primary adenocarcinoma of the rectum",
                    "criterion": "adenocarcinoma of the rectum",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "primary",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Distal border of the tumor within 12 cm of the anal verge by proctoscopic exam",
            "criterions": [
                {
                    "exact_snippets": "Distal border of the tumor within 12 cm of the anal verge",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "distance from anal verge",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "by proctoscopic exam",
                    "criterion": "method of measurement",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "proctoscopic exam"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T3-4",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N1-2",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stage II or III",
                    "criterion": "overall stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Physical exam",
            "criterions": [
                {
                    "exact_snippets": "Physical exam",
                    "criterion": "physical exam",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Transrectal ultrasound",
            "criterions": [
                {
                    "exact_snippets": "Transrectal ultrasound",
                    "criterion": "transrectal ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pelvic CT scan",
            "criterions": [
                {
                    "exact_snippets": "Pelvic CT scan",
                    "criterion": "pelvic CT scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pelvic MRI",
            "criterions": [
                {
                    "exact_snippets": "Pelvic MRI",
                    "criterion": "pelvic MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinical evidence of metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "No clinical evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "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 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Life expectancy",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 3 months",
            "criterions": [
                {
                    "exact_snippets": "More than 3 months",
                    "criterion": "time period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hematopoietic",
            "criterions": [
                {
                    "exact_snippets": "Hematopoietic",
                    "criterion": "hematopoietic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known, uncontrolled coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "No known, uncontrolled coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "awareness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT and SGPT ≤ 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "SGOT ... ≤ 1.5 times ULN",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGPT ... ≤ 1.5 times ULN",
                    "criterion": "SGPT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase ≤ 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 2.5 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine ≤ 1.5 times normal",
            "criterions": [
                {
                    "exact_snippets": "Creatinine ≤ 1.5 times normal",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance > 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance > 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cardiovascular",
            "criterions": [
                {
                    "exact_snippets": "Cardiovascular",
                    "criterion": "cardiovascular condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "No clinically significant cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic coronary artery disease",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No poorly controlled cardiac arrhythmias",
            "criterions": [
                {
                    "exact_snippets": "No poorly controlled cardiac arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No myocardial infarction within the past year",
            "criterions": [
                {
                    "exact_snippets": "No myocardial infarction within the past year",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Gastrointestinal",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal",
                    "criterion": "gastrointestinal condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active inflammatory bowel disease",
            "criterions": [
                {
                    "exact_snippets": "No active inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No lack of physical integrity of the upper gastrointestinal tract",
            "criterions": [
                {
                    "exact_snippets": "No lack of physical integrity of the upper gastrointestinal tract",
                    "criterion": "physical integrity of the upper gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No malabsorption syndrome",
            "criterions": [
                {
                    "exact_snippets": "No malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other prior or concurrent malignancy except inactive, non-invasive carcinoma of the cervix or non-melanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "No other prior or concurrent malignancy",
                    "criterion": "prior or concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except inactive, non-invasive carcinoma of the cervix",
                    "criterion": "carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "inactive"
                        },
                        {
                            "requirement_type": "invasiveness",
                            "expected_value": "non-invasive"
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent serious, uncontrolled infection(s)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent serious, uncontrolled infection(s)",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior unanticipated severe reaction to fluoropyrimidine therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior unanticipated severe reaction to fluoropyrimidine therapy",
                    "criterion": "reaction to fluoropyrimidine therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        },
                        {
                            "requirement_type": "anticipation",
                            "expected_value": "unanticipated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known sensitivity to fluorouracil",
            "criterions": [
                {
                    "exact_snippets": "No known sensitivity to fluorouracil",
                    "criterion": "sensitivity to fluorouracil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior uncontrolled seizures",
            "criterions": [
                {
                    "exact_snippets": "No prior uncontrolled seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No CNS disorders that would preclude study participation",
            "criterions": [
                {
                    "exact_snippets": "No CNS disorders that would preclude study participation",
                    "criterion": "CNS disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other medical or psychiatric condition that would preclude study participation",
            "criterions": [
                {
                    "exact_snippets": "No other medical ... condition that would preclude study participation",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other ... psychiatric condition that would preclude study participation",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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 during and for 3 months after study participation",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception during and for 3 months after study participation",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 3 months after study participation"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* No prior immunotherapy for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior immunotherapy for rectal cancer",
                    "criterion": "immunotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy for rectal cancer",
                    "criterion": "prior chemotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy for rectal cancer",
                    "criterion": "prior radiotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior pelvic radiotherapy",
                    "criterion": "prior pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Surgery",
            "criterions": [
                {
                    "exact_snippets": "Surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior major surgery and recovered",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior major surgery",
                    "criterion": "time since prior major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered",
                    "criterion": "recovery from prior major surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior surgery for rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior surgery for rectal cancer",
                    "criterion": "prior surgery for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior participation in another investigational drug study",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior participation in another investigational drug study",
                    "criterion": "time since prior investigational drug study",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent celecoxib",
            "criterions": [
                {
                    "exact_snippets": "No concurrent celecoxib",
                    "criterion": "celecoxib",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not specified",
            "criterions": []
        },
        {
            "line": "Other",
            "criterions": []
        }
    ]
}