Trial Information

Summary: NSABP R-04: A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum

BIOPSY:

You are being asked to take part in this research study because your doctor believes you may have rectal cancer.  Your doctor will take a small sample of the tissue (a biopsy) in your rectum to determine if it contains cancer cells.  We would like to have your doctor place some of this tissue in a special solution called “RNAlater®” at the same time that your biopsy is performed.  The tissue in RNAlater® will be sent to a group called the National Surgical Adjuvant Breast and Bowel Project (NSABP).  The NSABP is a group of researchers and doctors who are studying cancer.

 

 

TREATMENT:

You have been asked to participate in this research study because you have rectal cancer.  The purpose of this study is to compare the chemotherapy drug capecitabine as a pill by mouth, twice a day, during the weeks you receive radiation therapy is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given continuously into your vein during the weeks you receive radiation therapy. This study will look at two different treatment options and obtain important information regarding the quality of life for both.  At this time we do not know which chemotherapy drug, when combined with radiation therapy, is better for the type of cancer that you have.  The final purpose for doing this study is that the U.S. Food and Drug Administration (FDA) considers the use of capecitabine to be investigational for cancer such as yours.  Capecitabine in combination with radiotherapy must be tested further in patients with your type of cancer.

 

Your chemotherapy and radiation therapy will last about 6 weeks.  Even if your chemotherapy and radiation therapy are delayed due to side effects, they will not continue beyond 9 weeks.  We would like to keep track of your medical condition for the rest of your life to look at long-term effects of the study.

 

Patient Inclusion/Exclusion Criteria:


- See http://clinicaltrials.coh.org for additional information.

Contact:


City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Telephone: 866-896-HOPE (4673)

Profile Page: City of Hope, Duarte, CA

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Trial listings updated: October 6, 2008 at 2:28:26 PM


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