IORT Protocol for Colorectal CancerProtocol ISIORT-01: Phase III Comparison of IORT With vs. Without the Hypoxic Cell Sensitizer Etanidazole (with surgery, external beam irradiation and 5-FU/Leocovorin) for Recurrent or Locally Advanced Primary Colorectal Carcinoma Standard treatment with external irradiation and chemotherapy is not usually successful for advanced primary or locally recurrent colorectal cancer. Previous studies have shown that the drug, 5-fluorouracil (5-FU) makes external irradiation more effective and the drug, Leucovorin makes 5-FU more effective. The addition of surgery to remove as much tumor as possible, along with IORT, appears to increase local control of colorectal cancer as well. The drug, Etanidazole shows promise in making tumor cells more sensitive to IORT and, therefore, therapy combining Etanidazole with IORT may be even more effective in controlling this disease. The purpose of the Phase III Clinical Treatment Trial is to determine whether the addition of Etanidazole to IORT will lead to better tumor control and longer survival rates. Study Chairs: Leonard Gunderson, Dirk Noyes, Patrick Burch Participating Hospitals: USA
Europe
Japan
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