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Protocol R-04
A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
Specific Aims
Primary Aim
The primary aims of this study are to:
- Compare the rate of local-regional relapse in patients receiving preoperative oral capecitabine + radiotherapy (RT) to that in patients receiving preoperative continuous intravenous infusion (CVI) 5-FU + RT;
- Compare the rate of local-regional relapse in patients receiving preoperative oxaliplatin with those not receiving preoperative oxaliplatin.
The secondary aims of this study are to:
- Compare rate of cCR in patients receiving preoperative oral capecitabine + RT to that in patients receiving preoperative CVI 5-FU + RT;
- Compare rate of cCR in patients receiving preoperative oxaliplatin with those not receiving preoperative oxaliplatin;
- Compare rate of pCR in patients receiving preoperative oral capecitabine + RT to that in patients receiving preoperative CVI 5-FU + RT;
- Compare rate of pCR in patients receiving preoperative oxaliplatin with those not receiving preoperative oxaliplatin;
- Determine the increase in the number of patients able to undergo sphincter-saving surgery;
- Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis;
- Compare the impact of oral capecitabine versus CVI 5-FU on QOL in the setting of preoperative radiotherapy for rectal cancer;
- Evaluate the impact of oxaliplatin on neurotoxicity in the setting of preoperative radiotherapy for rectal cancer;
- Examine the differences in toxicity and convenience of care for the four chemotherapy treatment regimens;
- Describe the impact of the type of surgical management of rectal cancer on QOL at 1 year after surgical treatment.
