A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
Registration Inclusion Criteria:
• Diagnosis of rectal adenocarcinoma
• ECOG Performance Status (PS): 0, 1 or 2
• Preoperative proctoscopy with distal end of tumor tissue evident between 5 and 12 cm from the anal verge, inclusive. Tumors should not extend below 5cm. Tumors may extend above 12 cm provided distal tumor is located between 5-12 cm.
Registration Exclusion Criteria:
• Clinical T4 tumors
• Any prior pelvic radiation
Alison Conlin, M.D.
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