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 at http://cancer.gov/clinicaltrials/NSABP-C-09.

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

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 ¹ and capecitabine ². 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."

Who Can Join This Trial
Researchers will enroll 400 patients aged 18 and over with colorectal adenocarcinoma that has metastasized to the liver only. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NSABP-C-09.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/NSABP-C-09 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.