Randomized phase II trial of neoadjuvant combined modality therapy for locally advanced rectal cancer

A common way of treating patients with rectal cancer is to give radiation treatment to the pelvis region along with a drug called 5-fluorouracil (5-FU), and then, after a rest of several weeks, to do surgery to remove the tumor.  Sometimes rectal tumors that are either invading all the way through the muscle wall of the rectum or are invading into an organ or other important structure near the rectum do not do as well as we would want. The purpose of this study is to determine the effects of two treatments that add another drug to the radiation and 5-FU when the 5-FU is given as capecitabine. All of the drugs used in this study are commercially available cancer drugs. However, the combination of drugs used prior to surgery are considered investigational and not yet approved by the Food and Drug Administration (FDA) for this use.

You may be eligible to participate in this study if you:

• Are a patient with potentially resectable adenocarcinoma of the rectum located up to 12 cm from the anal verge without evidence of distant metastases
• Are at least 18 years of age
• Are a patient with clinical stage T3, based on endorectal ultrasound; or a patient with clinical stage T4 based on endorectal ultrasound or physical exam

This is a partial list of eligibility requirements. To determine your specific eligibility, please call the phone number provided.