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Name of the Trial

Phase III Randomized Study of Adjuvant Therapy Comprising Oxaliplatin and Capecitabine With Versus Without Hepatic Arterial Infusion of Floxuridine in Patients Undergoing Surgical Resection and/or Ablation for Hepatic Metastases From Colorectal Cancer (NSABP-C-09). See the protocol summary ³.

Principal Investigator

Dr. Lawrence D. Wagman, National Surgical Adjuvant Breast and Bowel Project.

Dr. Lawrence D. Wagman Principal Investigator

Why This Trial Is Important

When colorectal cancer metastasizes, it often spreads to the liver, where it forms tumors referred to as hepatic (or liver) metastases. In 25 to 50 percent of patients, doctors can use surgery or a method called tumor ablation to remove or destroy all visible tumors. Afterwards, they may also administer chemotherapy to help kill any remaining cancer cells.

In this trial, colorectal cancer patients with six or fewer hepatic metastases will undergo primary surgery and/or ablation and then be treated with oxaliplatin and capecitabine. Half of the patients will receive additional chemotherapy consisting of floxuridine pumped directly into their livers through an arterial catheter and pump. This treatment, known as hepatic arterial infusion, delivers a very high concentration of chemotherapy directly to the site of the tumors. Because floxuridine is readily metabolized by the liver, side effects in other parts of the body are rare.

"The addition of hepatic infusion chemotherapy to standard systemic chemotherapy has helped prolong the lives of patients with liver metastases that could not be removed," said Dr. Wagman. "With this trial, we want to extend this treatment to patients with tumors that can be removed and see if it will help those patients live longer without recurrence of their cancer, and possibly result in a cure for some of them."

Contact Information

This clinical trial is no longer accepting new patients. To locate other clinical trials for colon cancer, search the NCI database of clinical trials ⁴ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.

Glossary Terms

In medicine, the removal or destruction of a body part or tissue or its function. Ablation may be performed by surgery, hormones, drugs, radiofrequency, heat, or other methods.

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.

Treatment with drugs that kill cancer cells.

A drug used in the treatment of cancer. It is a type of antimetabolite.

To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor.

A drug used together 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.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.