Radiation Therapy With Capecitabine in Rectal Cancer
This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer.
This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur.
Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)|
- In patients with locally advanced rectal cancer treated with preoperative radiation and capecitabine chemotherapy to estimate:
- a. the pathologic complete response rate
- b. the clinical response rate
- c. the proportion of patients converted to sphincter sparing surgery
- clinical response rate [ Time Frame: 2 cycles ] [ Designated as safety issue: No ]
- d. The quantitative and qualitative toxicities of the treatment approach
- e. The relationship of intratumoral levels of thymidylate synthase, dipyrimidine dehydrogenase and thymidine phosphorylase determined immunohistochemically to response
|Study Start Date:||October 2000|
|Study Completion Date:||June 2007|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Zalupski, M.D.||University of Michigan Cancer Center|