Ongoing Clinical Trials Presently, the high priority adjuvant rectal cancer trial for the GI Intergroup is E5204, a randomized phase III study.[11] The goal of this two-arm study is to determine whether combination postoperative adjuvant therapy can improve disease-free and overall survival. Patients are randomized to receive modified FOLFOX6 with or without the anti-vascular endothelial growth factor (anti-VEGF) antibody bevacizumab, given for 12 cycles.
In Europe, the Spanish are conducting the GCR-3 randomized phase II study. The efficacy of neoadjuvant CAPOX (capecitabine [Xeloda], oxaliplatin) chemotherapy followed by chemoradiotherapy and surgical resection with no further adjuvant chemotherapy is being compared with chemoradiotherapy using CAPOX followed by surgery and postoperative CAPOX chemotherapy.