Fig. 6.1
Protocol schema for the phase II/III Preoperative Radiation or Selective Preoperative Radiation and Evaluation Before Chemotherapy and TME (PROSPECT) trial
The role for preoperative chemotherapy is being evaluated in both Europe and China as well. The BACCHUS trial is a phase II trial that is evaluating the efficacy and toxicity of six cycles of neoadjuvant FOLFOX plus bevacizumab versus six cycles of FOLFOXIRI plus bevacizumab (NCT01650428). Chemoradiation will be selectively utilized. In addition, a three-arm phase II study is being conducted in China which will randomize patients to four cycles of neoadjuvant FOLFOX versus FOLFOX-based chemoradiation versus radiation with 5-FU alone (NCT01211210). The results of the aforementioned trials are likely to either reaffirm our current treatment paradigm or reshape the face of treatment for locally advanced rectal cancer.
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