NSABP C-10 needs only six more patients to complete enrollment and prepare to answer the question: Is it safe and effective to leave a primary tumor without symptoms in the colon or rectum and proceed directly to chemotherapy in patients with colon cancer that has spread to distant organs where it cannot be surgically removed,
The trial has already enrolled 84 of the 90 patients with metastatic colon cancer needed.
All patients in the study will be treated with FOLFOX (oxaliplatin, leucovorin, and continuous infusion 5-FU) and Avastin® (bevacizumab) every two weeks for as long as their cancer doesn’t get worse and they are able to tolerate side effects.
The major goal of the study is to measure how often leaving a primary tumor in place causes a major problem that requires surgery or results in the patient dying. In addition, researchers will be looking at serious problems that don’t require surgery, side effects from treatment, and overall survival.
Eligible patients include those with:
- Colon cancer that has spread to a distant site in their body. (Stage IV)
- No previous chemotherapy, radiation, or surgery for the particular tumor.
- Primary tumor in the colon that has no symptoms such as bleeding or obstruction.
- Metastases in other parts of the body cannot be surgically removed. (unresectable)
The trial does not include patients with rectal cancer or cancer that has spread to their brain.
If treatment with chemotherapy makes it possible to remove metastases that were initally unresectable, patients will have both the mets and primary tumor removed surgically.
First opened in March, 2006, the trial is being conducted in a number of centers throughout the United States. You can contact a center near you for more information or to consider enrolling.