This phase 2 trial located in the United States aims to determine whether patients with rectal cancer have better outcomes with chemotherapy before chemoradiation (chemotherapy plus radiation) or after chemoradiation. The outcome to be measured is the number of patients who survive without cancer.
The details
In colorectal cancer, treatment includes surgery, medication and radiation. There are different types of chemotherapy regimens available. FOLFOX refers to a chemotherapy regimen which includes leucovorin, fluorouracil (5-FU) and oxaliplatin (Eloxatin). Cape-OX refers to another regimen which includes capecitabine plus oxaliplatin. These chemotherapy drugs work to stop cancer from growing.
Colorectal cancer patients often recieve chemotherapy and radiation at the same time, as a way of shrinking the tumor prior to surgery. Chemotherapy alone can also be used before or after chemoradiation. This trial will determine which treatment timing leads to longer disease-free survival (time without disease following treatment).
Who are they looking for?
This study is recruiting 222 patients with adenocarcinoma of the rectum. Patients should not have received prior radiation, chemotherapy or surgery for rectal cancer. Patients should have tumors that can be removed with surgery. Patients should not have had a heart attack, stroke, or chest pain within 6 months of enrolling in the study. Patients should not be pregnant or breastfeeding.
How will it work
Patients will be randomly assigned to one of 2 treatment groups.Patients in the first treatment group will receive chemotherapy before chemoradiation. They will first receive a chemotherapy regimen of FOLFOX or CapeOX over about 16-18 weeks. Patients who respond well will then have radiation together with either fluorouracil (Efudex)or capecitabine (Xeloda).
Patients in the second treatment group will receive chemoradiation before chemotherapy. Patients will first receive either fluorouracil or capecitabine together with radiation. Patients who respond well will then receive a chemotherapy regimen of FOLFOX or CapeOX.
