{
    "info": {
        "nct_id": "NCT00795301",
        "official_title": "A Randomized, Phase II Study of Concurrent Radiotherapy and Oxaliplatin, Capecitabine With or Without Cetuximab in Rectal Cancer Tumor Stratified by KRAS Mutation Status.",
        "inclusion_criteria": "1. All patients must have histologically or cytologically confirmed T3/4 and/or node positive adenocarcinoma of the rectum with the inferior border within 12 cm from the anal verge without evidence of distant metastases, as evaluated by computed tomography, ultrasonography, MRI or clinically.\n2. Patients must have normal organ and marrow function as defined below:\n\n   leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) greater than 2.5 X institutional upper limit of normal creatinine within normal institutional limits\n3. Age >21 years\n4. Patients must have ECOG performance status of 0-2.\n5. Patients must be 18 years old or greater.\n6. The tumor must be considered by the surgeon to be amenable to curative resection.\n7. Ability to understand and the willingness to sign a written informed consent document.\n8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\nHealthy volunteers allowed\nMust have minimum age of 21 Years",
        "exclusion_criteria": "1. Patients who have had prior chemotherapy or radiotherapy.\n2. Patients may not be receiving any other investigational agents.\n3. Patients with stage I or IV cancer of the rectum.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, oxaliplatin or capecitabine.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Inability to take oral medications.\n7. Pregnant women are excluded from this study because agents use in the study may cause fetal harm.\n8. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n9. History of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive cancer permitted if disease-free at least 5 years.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. All patients must have histologically or cytologically confirmed T3/4 and/or node positive adenocarcinoma of the rectum with the inferior border within 12 cm from the anal verge without evidence of distant metastases, as evaluated by computed tomography, ultrasonography, MRI or clinically.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed T3/4 and/or node positive adenocarcinoma of the rectum",
                    "criterion": "adenocarcinoma of the rectum",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T3",
                                "T4"
                            ]
                        },
                        {
                            "requirement_type": "node involvement",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "inferior border within 12 cm from the anal verge",
                    "criterion": "inferior border of the tumor",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluated by computed tomography, ultrasonography, MRI or clinically",
                    "criterion": "evaluation methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "computed tomography",
                                "ultrasonography",
                                "MRI",
                                "clinically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients must have normal organ and marrow function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "normal organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) greater than 2.5 X institutional upper limit of normal creatinine within normal institutional limits",
            "criterions": [
                {
                    "exact_snippets": "leukocytes >3,000/mcL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count >1,500/mcL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets >100,000/mcL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin within normal institutional limits",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within normal institutional limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "AST(SGOT)/ALT(SGPT) greater than 2.5 X institutional upper limit of normal",
                    "criterion": "AST(SGOT)/ALT(SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "greater than 2.5 X institutional upper limit of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine within normal institutional limits",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within normal institutional limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Age >21 years",
            "criterions": [
                {
                    "exact_snippets": "Age >21 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must have ECOG performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 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": "5. Patients must be 18 years old or greater.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be 18 years old or greater.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The tumor must be considered by the surgeon to be amenable to curative resection.",
            "criterions": [
                {
                    "exact_snippets": "tumor must be considered by the surgeon to be amenable to curative resection",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "amenability to curative resection",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "women of child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(hormonal or barrier method of birth control; abstinence)",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormonal",
                                "barrier",
                                "abstinence"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to study entry and for the duration of study participation",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "prior to study entry and for the duration of study participation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately",
                    "criterion": "pregnancy during study",
                    "requirements": [
                        {
                            "requirement_type": "action",
                            "expected_value": "inform treating physician immediately"
                        }
                    ]
                }
            ]
        },
        {
            "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 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who have had prior chemotherapy or radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have had prior ... radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients may not be receiving any other investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Patients may not be receiving any other investigational agents.",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with stage I or IV cancer of the rectum.",
            "criterions": [
                {
                    "exact_snippets": "stage I or IV cancer of the rectum",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer of the rectum",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "rectum"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, oxaliplatin or capecitabine.",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, oxaliplatin or capecitabine.",
                    "criterion": "allergic reactions to similar compounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Inability to take oral medications.",
            "criterions": [
                {
                    "exact_snippets": "Inability to take oral medications.",
                    "criterion": "ability to take oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnant women are excluded from this study because agents use in the study may cause fetal harm.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with docetaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.",
            "criterions": [
                {
                    "exact_snippets": "HIV-positive patients",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "on combination antiretroviral therapy",
                    "criterion": "combination antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. History of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive cancer permitted if disease-free at least 5 years.",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancies within 5 years",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma of the breast",
                    "criterion": "ductal carcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous invasive cancer permitted if disease-free at least 5 years",
                    "criterion": "previous invasive cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}