Focus on Clinical Trials
Can adding Avastin® (bevacizumab) to FOLFOX therapy after surgery and presurgical chemoradiotherapy reduce recurrence and improve survival for patients with rectal cancer?
A clinical trial to answer this question is underway and is looking for participants. Led by a team of researchers from several clinical trials cooperative groups, the E5204 study randomly assigns patients who have already completed a course of chemoradiotherapy and had their rectal cancer removed surgically to either FOLFOX or FOLFOX plus Avastin.
While surgery is the primary treatment for people with rectal cancer, cancer can return, both in or near the rectum (local recurrence) or at distant sites (metastases) in the body. Giving radiation enhanced with chemotherapy before or after surgery can reduce the risk of local recurrence and chemotherapy can improve overall survival. Cancer researchers are working on ways to improve treatment for rectal cancer, reducing recurrences and increasing the percentage of patients who are cured.
Phase III Randomized Study of Adjuvant Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Patients Who Have Undergone Surgery and Neoadjuvant Chemoradiotherapy for Stage II or III Rectal Cancer.
What is the goal of E5204?
The primary objective is to improve survival after treatment for rectal cancer. In addition, researchers will be looking at rates of local recurrence and side effects of treatment including long-term bowel function, diarrhea, and neuropathy. They will also be measuring a number of molecular markers to determine what effect they may have on survival.
Who can participate in E5204?
Stage II or III rectal cancer patients are eligible if they
- completed chemoradiotherapy before surgery
- had surgery to remove the rectal tumor between 4 and 8 weeks previously
- don’t have cancer that has spread to distant sites (metastasized)
- have no medical conditions or history that would make study treatment unsafe
How will the trial be conducted?
After understanding and signing an informed consent, patients will be assigned randomly (by chance) to one of two treatment arms:
- FOLFOX chemotherapy given every two weeks: intravenous oxaliplatin, leucovorin, and 5-FU on the first day followed by continuous infusion of 5-FU over the next 46 hours. Treatments are repeated every two weeks for 12 cycles (six months).
- FOLFOX chemotherapy plus intravenous Avastin (bevacizumab) on the first day.
You can find a site near you where the study is being conducted.
Under a special program, Medicare will pay for any additional costs that are involved in this trial for patients who have Medicare benefits. Ordinarily Medicare covers the cost of routine care during clinical trials. Private insurance may or may not cover routine medical care associated with a clinical trial, so check with your insurance about study coverage.
Why is this study important?
This trial and NSABP R-04, a clinical trial of chemoradiotherapy before surgery, are trying to discover if we can improve survival and other outcomes for patients with rectal cancer. Patients who have taken part in NSABP R-04 are also eligible for E5204, but you don’t have to have been in R-04 to enroll in this study after your surgery.
Dr. Al Benson, who is leading the trial says,
These two trials are intended to help define the best way to administer neoadjuvant and adjuvant treatment for rectal cancer. We hope to extend the benefits we have seen recently in adjuvant treatment for colon cancer to patients with rectal cancer.