IRB Number:

06-002377

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to test whether giving patients a combination of chemotherapy and radiation before the cancer is surgically removed with a procedure called local excision can effectively treat the cancer. We also want to find out what effect that treatment has on the patient's quality of life.

We hope that by giving patients the combination of chemotherapy and radiation before surgery, the tumor will shrink. This will allow the doctor to remove the cancer with a local excision, a surgical procedure designed to leave as much of the rectum and lower intestine intact as possible while still removing all of the cancer. This operation has a better chance of allowing patients to continue to have normal bowel function than the standard therapy for this kind of cancer.

Who is Eligible to Participate in the Study?

- Age 18 or older
- Diagnosed with invasive adenocarcinoma of the rectum
- More specific, detailed eligibility and/or exclusion criteria are associated with this trial.

What is Involved With this Study?

- Physical exam and a medical history
- X-ray, CT (computerized tomograph) or MRI (magnetic resonance imaging) scan
- ECG (electrocardiogram)
- Colonoscopy and proctoscopic examination
- Blood tests
- Pregnancy test for women potentially able to have children
- Ultrasound examination of the rectum
- Tumor biopsy
- Completion of questionnaires regarding bowel function and quality of life
- Combination of chemotherapy medication [Capecitabine (Xeloda), taken in pill form and Oxaliplatin, given through a vein] and radiation therapy before surgery
- Surgery (local excision) to remove the cancer and a small area of normal tissue surrounding it, followed by a 1 to 2-day hospital stay

How long will the Study run?

Patients will be in the study for approximately 5 years. The study doctor will also ask patients to visit the office for follow-up exams one month after surgery and then every 4 months for 3 years. After this, patients will need to come in for check-ups once every 6 months for 2 years.

Sponsor(s): American College of Surgeons Oncology Group (ACOSOG)

Study Activation/Registration Date: 07/25/2006

IRB Review and Approval Date: 06/08/2006

Study Type: Treatment

Projected Accrual: The plan is to have about 85 patients participate in this study from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Bruce Wolff, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/27/2009