This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is an ECOG-sponsored, randomized phase II trial of FOLFOX plus Avastin versus FOLFOX versus observation in patients with resected stage II colon cancer. The primary objective is to demonstrate an improvement in 3-year disease-free survival. The secondary objectives are to compare overall survival, further define toxicity profiles, and prospectively determine the impact of tumor biological characteristics (molecular markers) on the survival of these patients. A total of 3610 patients with stage II colon cancer will be studied (10 at NYU). The current standard treatment is combination chemotherapy. The study hypothesizes that 40% of stage-II colon cancer patients will fall into the high-risk patient group, defined by a microsatellite-stable tumor with 18q LOH, and 60% will fall into the low-risk group, defined by a tumor with high levels of microsatellite instability or microsatellite stability with retention of 18q alleles. The low-risk group of stage-II patients will have a 5-year survival of approximately 90%, whereas the high-risk stage-II patients will have a 60% 5-year survival. The addition of the anti-VEGF monoclonal antibody bevacizumab will improve survival in patients with high-risk stage-II disease in combination with 5-FU, leucovorin and oxaliplatin compared to those high-risk patients randomized to receive 5-FU, leucovorin and oxaliplatin.
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