This trial is examining the effectiveness of chemotherapy followed by a less invasive surgery for early rectal cancer. The main outcome will be the number of patients keeping their rectum. This trial is being conducted in Canada and the United States.
Rectal cancer is one of the most common cancers in the US. The standard therapy is chemotherapy and surgery. However, radical rectal surgery (the tumor and other surrounding organs/tissues are removed) is associated with a high rate of complications. These affect the quality of life of these patients. Patients who respond to chemotherapy and have tumor shrinkage are more likely to receive a less invasive surgery.
This study is evaluating the effectiveness of chemotherapy followed by less invasive surgery for early rectal cancer. The main outcome of this study will be measured by the number of patients who keep their rectum.
Who are they looking for?
This trial is looking for 58 participants with early rectal cancer. Patients must have adequate kidney and liver function tests and be available to start treatment within 5 working days of patient enrolment.
Patients must not have history of other cancers, prior treatment for rectal cancer, prior pelvic radiation, heart disease and must not be pregnant or breastfeeding.
How will it work
All participants will be assigned to receive treatment with the chemotherapy FOLFOX or CAPOX. Patients in the FOLFOX group will receive therapy 2 times per week for 6 cycles. Patients in the CAPOX group will receive therapy 3 times per week for 4 cycles. Chemotherapy will then be followed by surgical removal of the tumor.
The main outcome will be measured by the number of patients that keep their rectum. Survival and side effects will also be measured up to 3 years.