A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
You are being asked to take part in this study because you have been diagnosed with rectal cancer that has extended through the rectal wall (Stage II), or involves the lymph nodes outside the rectum (Stage III).
Patients with rectal cancer are given chemotherapy and radiation therapy, and then they have surgery to remove the rectum. Chemotherapy and radiation therapy are given at the same time. This is called chemoradiation. Sometimes after surgery, patients will have extra chemotherapy without radiation. The extra chemotherapy is given to help make sure the tumor does not come back and to try and cure patients of their cancer.
The purpose of this study is to increase the number of patients cured from their rectal cancer by giving the extra chemotherapy before surgery instead of after surgery. We also want to find out what effects, good and/or bad, having chemotherapy before surgery has on you and your rectal cancer. We believe that it will be better for you to have chemotherapy before surgery, but we are not sure if it is better to give the chemotherapy before or after the chemoradiation.
Another important purpose of this study is to try and avoid surgery in patients with rectal tumors that have disappeared in response to the chemoradiation and the chemotherapy given before surgery. We believe that having additional chemotherapy before surgery may improve the chances that your tumor will disappear and we will be able to save your rectum.
N1048: Phase II/III Trial of Neoadjuvant FOLFOX, for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.