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Featured Clinical Trials

Cancer Studies Highlighted in the NCI Cancer Bulletin
  • Posted: 05/09/2006

Neoadjuvant Therapy for Rectal Cancer

Name of the Trial

Randomized Study of Preoperative Chemoradiotherapy Comprising Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin in Patients With Resectable Rectal Cancer (NSABP-R-04). See the protocol summary 1.

Principal Investigators

Dr. Robert Beart, National Surgical Adjuvant Breast and Bowel Project, and Dr. David Ryan, Cancer and Leukemia Group B.

Dr. Robert Beart
Dr. Robert Beart
Principal Investigator

Why This Trial Is Important

More than 40,000 new cases of rectal cancer are diagnosed each year in the United States. Surgery is the primary form of treatment for rectal cancer, but recurrence is common using surgery alone.

Presurgical treatment with chemotherapy and radiation therapy, known as neoadjuvant therapy, may help prevent cancer recurrence in the region around rectal tumors. Furthermore, neoadjuvant therapy has been shown to reduce the size of rectal tumors before surgery, and it may allow more patients to undergo sphincter-saving procedures. Preserving sphincter function without increasing the risk of local or regional recurrence is an important consideration in the treatment of rectal cancer.

To be eligible for this trial, patients must have rectal tumors that can be completely removed by surgery. They will be treated with chemotherapy and radiation therapy at the same time for five to six weeks before surgery. They will be divided into four groups based on the type of chemotherapy administered: intravenous (IV) 5-fluorouracil (5-FU) alone, IV 5-FU plus IV oxaliplatin, oral capecitabine alone, and oral capecitabine plus IV oxaliplatin.

"We hope to improve neoadjuvant therapy for rectal cancer with the use of oral capecitabine and addition of oxaliplatin and, through the collection of tissue samples, learn how to identify those patients who will benefit from neoadjuvant therapy," said Dr. Beart.

Who Can Join This Trial

Researchers seek to enroll 1,606 patients aged 18 and over with stage II or III rectal cancer that can be surgically removed. See the list of eligibility criteria 2. This trial is eligible for special Medicare coverage 3.

Study Sites and Contact Information

Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites and contacts 4 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

Related Pages



Glossary Terms

capecitabine (ka-peh-SY-tuh-been)
A drug used to treat stage III colon cancer in patients who had surgery to remove the cancer. It is also used to treat metastatic breast cancer that has not improved after treatment with certain other anticancer drugs. Capecitabine is being studied in the treatment of other types of cancer. It is taken up by cancer cells and breaks down into 5-fluorouracil, a substance that kills tumor cells. Capecitabine is a type of antimetabolite. Also called Xeloda.
chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
fluorouracil (floor-oh-YOOR-uh-sil)
A drug used to treat cancers of the breast, stomach, and pancreas, and certain types of colorectal and head and neck cancers. It is also used in a cream to treat basal cell skin cancer and actinic keratosis (a skin condition that may become cancer). It is being studied in the treatment of other conditions and types of cancer. Fluorouracil stops cells from making DNA and it may kill cancer cells. It is a type of antimetabolite. Also called 5-fluorouracil, 5-FU, Adrucil, Efudex, and Fluoroplex.
oxaliplatin (ok-SA-lih-pla-tin)
A drug used with other drugs to treat colorectal cancer that is advanced or has come back. It is also being studied in the treatment of other types of cancer. Oxaliplatin attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Eloxatin.
radiation therapy (RAY-dee-AY-shun THAYR-uh-pee)
The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
recurrence (ree-KER-ents)
Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrent cancer.
sphincter (SFINK-ter)
A ring-shaped muscle that relaxes or tightens to open or close a passage or opening in the body. Examples are the anal sphincter (around the opening of the anus) and the pyloric sphincter (at the lower opening of the stomach).

Table of Links

1http://cancer.gov/clinicaltrials/NSABP-R-04
2http://www.cancer.gov/clinicaltrials/NSABP-R-04#EntryCriteria_CDR0000298755
3http://www.cancer.gov/clinicaltrials/conducting/developments/ncd179n
4http://www.cancer.gov/clinicaltrials/NSABP-R-04#ContactInfo_CDR0000298755
5http://www.cancer.gov/clinicaltrials/search
6http://www.cancer.gov/cancertopics/types/colon-and-rectal