Adjuvant Therapy for Stage II Colon Cancer
Name of the Trial
Phase III Randomized Study of Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Bevacizumab in Patients With Resected Stage II Colon Cancer and at High Risk for Recurrence Based on Molecular Markers (ECOG-E5202). See the protocol summary.
Dr. Al Benson, Dr. Peter O'Dwyer, and Dr. Stanley Hamilton, Eastern Cooperative Oncology Group.
Why This Trial Is Important
In this trial, researchers are using molecular tests to help identify patients who are at high risk for recurrence after colon cancer surgery. Those deemed at high risk will receive adjuvant chemotherapy (drug therapy given after surgery to help suppress cancer recurrence). Half of the high-risk patients will also receive adjuvant treatment with bevacizumab, a monoclonal antibody that blocks the activity a protein called vascular endothelial growth factor (VEGF). Tumors often produce large quantities of VEGF, which stimulates the growth of new blood vessels that help provide nourishment. Blocking VEGF may inhibit this new blood vessel growth and prevent continued tumor growth. Patients at low risk for recurrence will not receive adjuvant therapy but will continue to be monitored.
"Because patients with stage II colon cancer generally have good survivorship, it is hard to measure the impact of adjuvant therapy for these patients," said Dr. Benson. "This is one of the largest trials for patients with stage II colon cancer ever conducted, so we hope to determine conclusively whether or not adjuvant therapy is helpful. Additionally, this trial is the first of its kind to use molecular tests to determine how patients will be treated after surgery."
Who Can Join This Trial
Researchers seek to enroll 3,610 patients aged 18 and over with stage II colon cancer that has been surgically removed. See the list of eligibility criteria.
This trial is eligible for special Medicare coverage. See Clinical Trials Covered Under the Medicare Anti-Cancer Drug National Coverage Decision.
Study Sites and Contact Information
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites 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.