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Rectal Cancer: Phase II/III study of FOLFOX chemotherapy with or without radiation treatment before surgery for locally advanced rectal cancer. (N1048)

Research Question:
This study will compare the effects of the standard treatment of chemotherapy and radiation to chemotherapy alone in treating rectal cancer.

Basic Study Information

Purpose:
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. This results in high rates of disease control with significant side effects. The purpose of this study is to compare the effects of the standard treatment of chemotherapy and radiation to chemotherapy alone. The aim of this study is to determine if we can reduce the side effects while still controlling the disease. The chemotherapy alone is the combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin). Depending on the response to FOLFOX you may also receive the standard treatment 5FUCMT. The drugs used in this study are all FDA (Food and Drug Administration) approved for the treatment of colorectal cancer. The use of FOLFOX chemotherapy alone in place of 5FUCMT is experimental. In case FOLFOX chemotherapy alone does not work, you will receive standard treatment which is 5FUCMT followed by surgery.

Location: Cancer center
Study Web URL:  http://clinicaltrials.gov/ct2/show/NCT01515787?term=N1048&rank=1
Study Reference #: CGIC-13038

Lead Researcher (Principal Investigator)

Lead Researcher: Mohamedtaki Tejani, MD

Study Contact Information

Study Coordinator: Tanya Smith
Phone: (585) 275-8213
Email: Tanya_Smith@urmc.rochester.edu

Additional Study Details

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