IRB Number:

06-003779

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done with patients with rectal cancer to:
- See if taking a drug called capecitabine as a pill, twice a day by mouth during the weeks a patient receives radiation therapy, is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given continuously into a patient's vein during the weeks the patient receives radiation therapy.
- See if adding oxaliplatin to capecitabine and 5-FU can improve how well these drugs work. At this time researchers do not know which chemotherapy drugs, when combined with radiation therapy, are most effective for this type of cancer.
- Look at the four different treatment options by obtaining important information regarding quality of life.
- The U.S. Food and Drug Administration (FDA) currently considers the use of both capecitabine and oxaliplatin to be investigational when given before surgery to remove this type of cancer.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Patient with Stage II or III and a diagnosis of adenocarcinoma of the rectum obtained by a biopsy technique that leaves the major portion of the tumor intact

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Before beginning the study, patients will need to have the following exams and medical tests.

If patients have had any of them recently, their doctor may decide not to repeat them:
- physical exam
- routine blood tests
- chest X-ray or chest CT scan (a CT scan is a test that uses computers and X-rays to create pictures of the body's organs.)
- CT scan, combined PET/CT scan, or MRI of the abdomen and pelvis (the MRI scan uses magnetic waves to create clear pictures of the body.)
- exams of rectum and colon
- transrectal ultrasound or endoluminal utrasound or MRI with endocoil. One of these procedures will be used and includes the use of a probe to examine the rectum and
record pictures of the rectal tumor. The doctor will decide which of these tests is the best for the patient
- serum pregnancy test if the patient is a female of child-bearing potential

These exams and tests are part of standard good medical care even if the patient does not join this study. They may be done on an outpatient basis at the patient's doctor's office or clinic, or in a hospital.

If patients have not already had a sample of tissue (a biopsy) collected in a solution called RNAlater, they will be asked if they are willing to have an additional biopsy so that a sample of the tissue can be collected in this solution and used for research. This will only be done if the patient agrees to have an additional biopsy. If the patient does not agree to have an additional biopsy, the patient can still take part in this study. If the patient agrees to have an additional biopsy, the patient or the patient's insurance company will not be charged for it.

If the tests and exams show that the patient can participate in the study, and the patient agrees to take part, the patient will be put in one of four groups by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to one of the four study groups. Neither the patient nor the study doctor will choose the group for the patient. The patient will have an equal chance of being placed in any of the four groups.

Group 1: The patient will receive 5-FU through their vein continuously over 24 hours a day for five days a week on the days the patient is scheduled to receive radiation therapy. The patient will receive radiation therapy five days a week (not on weekends) for five to six weeks. The doctor will need to put a temporary tube into a vein in the patient's chest or arm to receive the 5-FU continuously.

Group 2: The patient will receive oxaliplatin through a vein once every week for five weeks beginning on the first day of radiation therapy. The patient will also receive 5-FU through the vein continuously over 24 hours a day five days a week on the days the patient is scheduled to receive radiation therapy. The patient will receive radiation therapy five days a week (not on weekends) for five to six weeks. The doctor will need to put a temporary tube into a vein in the patient's chest or arm so the patient can receive the 5-FU continuously.

Group 3: The patient will take capecitabine twice a day by mouth (within 30 minutes after eating breakfast and dinner) five days a week on the days scheduled to receive radiation therapy. The doctor may ask the patient to write in a diary or on a calendar each dose of capecitabine that the patient takes. The patient will receive radiation therapy five days a week (not on weekends) for five to six weeks.

Group 4: The patient will receive oxaliplatin through a vein once every week for five weeks beginning on the first day of radiation therapy. The patient will take capecitabine twice a day by mouth (within 30 minutes after eating breakfast and dinner) five days a week on the days they are scheduled to receive radiation therapy. The doctor may ask the patient to write in a diary or on a calendar each dose of capecitabine that the patient takes. The patient will receive radiation therapy five days a week (not on weekends) for five to six weeks.

For all patients:
Patients will have a physical exam and blood work every week while they are receiving therapy.

Patients will be asked to complete a questionnaire 1) before starting their treatments, 2)toward the completion of their radiation treatments, and 3) one year after their surgery. This questionnaire will ask how the patient is functioning physically and emotionally, and about any symptoms the patient may be having from the cancer or the treatments. It should take about 20 to 30 minutes to complete, which can be done in the office while the patient is waiting to see the doctor. This type of questionnaire focuses on quality of life issues, as the research staff feel it is best to learn directly from the patient about how the treatments are affecting their everyday activities.

Also, before a patient begins treatment, a blood sample (approximately six teaspoons) will be collected if the patient agrees to the collection and use of their blood sample for research. This sample will be compared to a blood sample collected after the patient's treatment ends but before surgery.

After the treatment: After completing chemotherapy and radiation therapy, the patient will undergo surgery to remove any remaining tumor. After surgery, the doctor will ask the patient to return for physical examinations every six months for five years. The patient will have blood tests before their surgery and then every six months for five years after surgery. The patient will need to have an exam of the area of their rectum where their tumor had been at one, two and three years after surgery. The patient will also need to have a CT scan (which may include a PET scan) or MRI of their abdomen and pelvis at one and two years after surgery. Patients should talk to their doctor about receiving additional treatment (chemotherapy) after they receive surgery.

How long will the Study run?

Patients will participate in the study for five years after their surgery.

Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP), National Cancer Institute (NCI), Cancer and Leukemia Group B (CALGB)

Study Activation/Registration Date: 02/20/2008

IRB Review and Approval Date: 01/18/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 1606 patients participate from multiple medical centers.

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

Principal Investigator: Henry C. Pitot, 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
• Jacksonville, FL

Last updated: 05/20/2009