If you are diagnosed with stage III colon cancer, you will probably receive about six months of treatment with FOLFOX after surgery. Research shows that this treatment regimen helps prevent recurrence for some – but not all – patients with stage III colon cancer. A clinical trial has been launched to answer two questions about this current standard of care:
1. Will recurrence rates go down if both FOLFOX and celecoxib (a non-steroidal anti-inflammatory drug similar to aspirin) are used for treatment?
2. Will recurrence rates stay the same and long term side effects decrease if FOLFOX is used for three months?
FOLFOX can cause short- and long-term neuropathy, a numbness and tingling in hands and feet that makes activities like buttoning shirts hard. Long-term neuropathy seems to be related to the total amount of FOLFOX received. Celecoxib has been shown to prevent the formation of polyps, and the development of colon cancer in patients who have had polyps.
Patients in the trial will be randomized to one of four treatment arms:
- Six months of FOLFOX (standard of care)
- Six months of FOLFOX plus celecoxib for three years
- Three months of FOLFOX
- Three months of FOLFOX plus celecoxib for three years
Patients will be monitored for the course of the clinical trial by the treating physicians. Overall patient safety and treatment efficacy will be monitored by a Data Safety Monitoring Committee. As always, patients who participate in clinical trials may or may not directly benefit from the trial. They contribute to the treatment of future patients, whose treatment will be influenced by the results of this trial.
This trial is called the CLEAR Colon Trial. It is being conducted by a national, publicly-funded clinical trial network called the Cancer and Leukemia Group B (CALGB) and is supported by the National Cancer Institute. For more information, read or download this informational document or visit the Fight Colorectal Cancer Clinical Trial Matching Service.