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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 ³.

Principal Investigators

Dr. Al Benson, Dr. Peter O'Dwyer, and Dr. Stanley Hamilton, Eastern Cooperative Oncology Group.

Dr. Al Benson Principal Investigator

Why This Trial Is Important

Colon cancer is highly treatable and often curable if detected early. However, cancer recurrence after surgery to remove malignant colon tumors remains a concern.

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 ⁴.

This trial is eligible for special Medicare coverage. See Clinical Trials Covered Under the Medicare Anti-Cancer Drug National Coverage Decision ⁵.

Study Sites and Contact Information

Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites ⁶ 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.

Glossary Terms

A drug used to treat several types of cancer, including certain types of colorectal, lung, breast, and kidney cancers and glioblastoma. It is also being studied in the treatment of other types of cancer. Bevacizumab binds to vascular endothelial growth factor (VEGF) and may prevent the growth of new blood vessels that tumors need to grow. It is a type of antiangiogenesis agent and a type of monoclonal antibody. Also called Avastin.

Cancerous. Malignant tumors can invade and destroy nearby tissue and spread to other parts of the body.

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.

Cancer has spread outside the colon and/or rectum to nearby tissue, but it has not gone into the lymph nodes. Also called Dukes B colorectal cancer.

In cancer, survivorship covers the physical, psychosocial, and economic issues of cancer, from diagnosis until the end of life. It focuses on the health and life of a person with cancer beyond the diagnosis and treatment phases. Survivorship includes issues related to the ability to get health care and follow-up treatment, late effects of treatment, second cancers, and quality of life. Family members, friends, and caregivers are also part of the survivorship experience.