{
"info": {
"nct_id": "NCT00006366",
"official_title": "Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the distal rectum\n\n * Located 0-9 cm from the dentate line (3-12 cm from the anal verge)\n\n * No extension of malignant disease into the anal canal\n* Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation\n* No evidence of distant metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* Zubrod 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC (white blood cell count) greater than 4,000/mm^3\n* Platelet count greater than 130,000/mm^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal\n* Alkaline phosphatase, SGOT (serum glutamic oxaloacetic transaminase), and LDH (lactate dehydrogenase) normal\n\nRenal:\n\n* Creatinine normal\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other invasive malignancy within the past 5 years except:\n\n * Inactive nonmelanomatous skin cancer\n * Carcinoma in situ of the cervix\n * Synchronous colonic cancer if tumor is Tis or T1 and has been completely resected\n* No other serious medical illnesses\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy to pelvis\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent antiepileptic drugs"
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Chemotherapy",
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}
}
]
},
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{
"exact_snippets": "Chemotherapy",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "No prior chemotherapy",
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}
}
]
},
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{
"exact_snippets": "No prior chemotherapy",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Endocrine therapy",
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}
}
]
},
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{
"exact_snippets": "Endocrine therapy",
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]
}
},
{
"identified_line": {
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{
"exact_snippets": "Radiotherapy",
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}
]
},
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"exact_snippets": "Radiotherapy",
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}
},
{
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}
}
]
},
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}
}
},
{
"identified_line": {
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"exact_snippets": "Surgery",
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"exact_snippets": "Surgery",
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}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
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},
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"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
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},
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"and_criteria": []
}
},
{
"identified_line": {
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},
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}
},
{
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{
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}
},
{
"identified_line": {
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},
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"and_criteria": []
}
},
{
"identified_line": {
"line": "* Not specified",
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},
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"and_criteria": []
}
},
{
"identified_line": {
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},
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"and_criteria": []
}
},
{
"identified_line": {
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}
],
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"failed_exclusion": [],
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{
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{
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}
}
}
]
}