{
    "info": {
        "nct_id": "NCT00693173",
        "official_title": "Genital Drop Technique With Intensity-Modulated Radiation Therapy (IMRT) in Male Anal and Distal Rectal Cancer Patients: A Dosimetric Comparison",
        "inclusion_criteria": "* Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively.\n* Any histological grade.\n* Age: >18 years.\n* Gender: Male patients with average external genitalia.\n* Race: Any.\n* Language: English speaking only.\n* Performance status: Good (Karnofsky Performance Status of >60%). (ECOG 0-2).\n* UTMB patients\n* Stages: Early local disease to locoregionally advanced disease per the 2002 American Joint Committee on Cancer (AJCC) Staging System.\n* Anal Cancer: Stages I-IIIB (see Section 11).\n* Distal Rectal Cancers that pass the dentate line and into the anal canal only: Stages IIA-IIIC (see Section 11).\n\nExclusion Criteria\n\n* Histological variants other than those listed above in 4.a.\n* Patients with cystocele or abnormal scrotal edema will be excluded. (Although the Genital Drop Technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy).\n* 2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0) patients).\n* Performance status: Poor (Karnofsky Performance Status of <60%). (ECOG 3-4).\n* Non-English speaking patients.\n* Prior pelvic radiation.\n* Prior pelvic malignancy.\n* Anal cancer/rectal cancer surgery, except for biopsy at study site.\n* Patient's mental condition and social support is such that he can neither understand the nature of the protocol nor comply with its requirements.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively.",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma)",
                    "criterion": "anal cancer type",
                    "requirements": [
                        {
                            "requirement_type": "histological type",
                            "expected_value": [
                                "squamous",
                                "basaloid",
                                "cloacogenic carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "distal rectal cancer (adenocarcinoma variants)",
                    "criterion": "rectal cancer type",
                    "requirements": [
                        {
                            "requirement_type": "histological type",
                            "expected_value": "adenocarcinoma variants"
                        }
                    ]
                },
                {
                    "exact_snippets": "traverse the dentate line",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "traverse the dentate line"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for definitive chemoradiation",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "definitive chemoradiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for ... preoperative radiation therapy",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "preoperative radiation therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any histological grade.",
            "criterions": [
                {
                    "exact_snippets": "Any histological grade",
                    "criterion": "histological grade",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age: >18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age: >18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gender: Male patients with average external genitalia.",
            "criterions": [
                {
                    "exact_snippets": "Gender: Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "average external genitalia",
                    "criterion": "external genitalia",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "average"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Race: Any.",
            "criterions": [
                {
                    "exact_snippets": "Race: Any.",
                    "criterion": "race",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "Any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Language: English speaking only.",
            "criterions": [
                {
                    "exact_snippets": "English speaking only",
                    "criterion": "language",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": "English"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status: Good (Karnofsky Performance Status of >60%). (ECOG 0-2).",
            "criterions": [
                {
                    "exact_snippets": "Performance status: Good (Karnofsky Performance Status of >60%)",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: Good ... (ECOG 0-2)",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* UTMB patients",
            "criterions": [
                {
                    "exact_snippets": "UTMB patients",
                    "criterion": "institution affiliation",
                    "requirements": [
                        {
                            "requirement_type": "affiliation",
                            "expected_value": "UTMB"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stages: Early local disease to locoregionally advanced disease per the 2002 American Joint Committee on Cancer (AJCC) Staging System.",
            "criterions": [
                {
                    "exact_snippets": "Stages: Early local disease to locoregionally advanced disease",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "per the 2002 American Joint Committee on Cancer (AJCC) Staging System",
                    "criterion": "staging system",
                    "requirements": [
                        {
                            "requirement_type": "specificity",
                            "expected_value": "2002 AJCC Staging System"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anal Cancer: Stages I-IIIB (see Section 11).",
            "criterions": [
                {
                    "exact_snippets": "Anal Cancer: Stages I-IIIB",
                    "criterion": "anal cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Distal Rectal Cancers that pass the dentate line and into the anal canal only: Stages IIA-IIIC (see Section 11).",
            "criterions": [
                {
                    "exact_snippets": "Distal Rectal Cancers that pass the dentate line and into the anal canal only",
                    "criterion": "distal rectal cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pass the dentate line and into the anal canal only"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stages IIA-IIIC",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIA",
                                "IIB",
                                "IIC",
                                "IIIA",
                                "IIIB",
                                "IIIC"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological variants other than those listed above in 4.a.",
            "criterions": [
                {
                    "exact_snippets": "Histological variants other than those listed above in 4.a.",
                    "criterion": "histological variants",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "those listed above in 4.a."
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with cystocele or abnormal scrotal edema will be excluded. (Although the Genital Drop Technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy).",
            "criterions": [
                {
                    "exact_snippets": "Patients with cystocele",
                    "criterion": "cystocele",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal scrotal edema",
                    "criterion": "scrotal edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2002 American Joint Committee on Cancer (AJCC) Staging System. (Anal Cancer: Stage IV.; Distal Rectal Cancer: Stage IV, and tumor 2-node 0-metastasis 0 (T1-T2N0M0) patients).",
            "criterions": [
                {
                    "exact_snippets": "Anal Cancer: Stage IV",
                    "criterion": "anal cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "Distal Rectal Cancer: Stage IV",
                    "criterion": "distal rectal cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor 2-node 0-metastasis 0 (T1-T2N0M0)",
                    "criterion": "tumor-node-metastasis classification",
                    "requirements": [
                        {
                            "requirement_type": "tumor",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "T1-T2"
                            }
                        },
                        {
                            "requirement_type": "node",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "N0"
                            }
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M0"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status: Poor (Karnofsky Performance Status of <60%). (ECOG 3-4).",
            "criterions": [
                {
                    "exact_snippets": "Performance status: Poor (Karnofsky Performance Status of <60%)",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: Poor ... (ECOG 3-4)",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-English speaking patients.",
            "criterions": [
                {
                    "exact_snippets": "Non-English speaking patients",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "non-English"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior pelvic radiation.",
            "criterions": [
                {
                    "exact_snippets": "Prior pelvic radiation.",
                    "criterion": "pelvic radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior pelvic malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Prior pelvic malignancy",
                    "criterion": "pelvic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anal cancer/rectal cancer surgery, except for biopsy at study site.",
            "criterions": [
                {
                    "exact_snippets": "Anal cancer/rectal cancer surgery, except for biopsy at study site.",
                    "criterion": "anal cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Anal cancer/rectal cancer surgery, except for biopsy at study site.",
                    "criterion": "rectal cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient's mental condition and social support is such that he can neither understand the nature of the protocol nor comply with its requirements.",
            "criterions": [
                {
                    "exact_snippets": "Patient's mental condition ... can neither understand the nature of the protocol",
                    "criterion": "mental condition",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient's ... social support is such that he can neither ... comply with its requirements",
                    "criterion": "social support",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}