Clinical Trial

Randomized trial comparing preoperative radiation therapy and capcetabine with preoperative radiation therapy and continuous infusion of 5-FU for patients with operable carcinoma of the rectum
 

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

Exclusion Criteria
• 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

Treatment
• 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.

 
 
Contact
Jamila A. Mwidau, RN, BSN,MPH
Sr. Research Nurse/Coordinator
Tel: 410-502-2673
Email: Jamila@jhu.edu
 
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