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Status: RecruitingPhase: Phase 2/Phase 3Diagnosis: Colorectal Cancer, Gastrointestinal MalignanciesNCT ID: NCT01515787
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-023
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 the 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 to treat patients with advanced colorectal cancer.
Conducting Institutions: Dana-Farber Cancer Institute, Brigham and Women's Hospital, DF/BWCC at South Shore Hospital, Dana Farber Cancer Institute at Milford, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center
Overall PI: Rolf Freter, MD, Ph.D.,
Dana Farber Cancer Institute at South Shore
Site-responsible Investigators: Deborah Schrag, MD, MPH,
Dana Farber Cancer InstituteMichael Constantine, M.D.,
Dana Farber Cancer Institute at Milford HosptialDavid P. Ryan, MD,
Massachusetts General Hospital
Contacts: Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100