A randomized clinical trial comparing preoperative radiation therapy (XRT) and capcetabine with preoperative radiation therapy and continuous intravenous infusion (CVI) of 5-flourouracil (5-FU) in the treatment of patients with operable carcinoma of the rectum
Protocol number: NSABPR04
Type of cancer: rectal cancer
Physician: Susan Gearhart, M. D., Surgical Oncologist
Phase number: II/III
General eligibility: Patients with documented rectal cancer who are/have:
• in good physical condition
• a deemed resectable tumor
• good blood counts; and good organ function
• prior chemotherapy and/or radiation therapy for the treatment of this cancer
Purpose: The primary aim of this study is to compare the results of patients receiving preoperative oral capecitabine (Xeloda®), a pill form of 5-FU, given concurrently with radiation therapy, versus patients receiving a continuous intravenous infusion of 5-FU.
The goals of this study are:
• to obtain durable, local/regional tumor control
• to downstage the primary tumor
• to increase the number of patients undergoing sphincter-saving surgery
• Some patients will receive oral capecitabine in combination with radiation therapy.
• Some patients will receive a continuous intravenous infusion of 5-FU.
• Patients will be placed randomly in either group.
• Side effects and the patients’ quality of life will be monitored, as well as the tumor itself.