A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
Principal Investigator (?)
The Principal Investigator is the doctor responsible for conducting the clinical trial.
Ivatury, Srinivas
Study Number
N1048
Summary
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.
Phase (?)
Phase III
Sponsor (?)
Alliance - NCI Cooperative Group
Available at the following location(s)
St. Johnsbury, VT
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