Phase II, Non-Randomized Study of Chemo-Chemoradio-Chemo Sequential Therapy Compared With Concomitant Chemoradiotherapy In Magnetic Resonance Imaging Defined, Locally Mid/Low Advanced Rectal Cancer

Abstract

\n ObjectiveThe conventional preoperative CRT provides local tumor control in most LARC patients. However, long-term survival has not obviously improved. Thus, the optimal neoadjuvant treatment is still controversial. Sandwich therapy may be associated with better efficacy.Methods The present study is a single-center, open-label, phase II, non-randomized trial (Clinical trials number: NCT02022852). Pathological diagnosis of eligible patients were as rectal adenocarcinoma and they were clinically confirmed by MRI as cT3-4NxM0, with distal border located＜10cm from anal verge. Hundred and seventy-two patients between July 2013 and July 2015 were enrolled for the trial. The enrolled patients were non-randomly assigned into two treatment types (arm A and arm B). Patients in arm A received capecitabine-based concurrent CRT 25 fractions. In contrast, arm B patients received sequential therapy as induction CapeOx for two cycles, followed by 25 fractions CRT, finally adding one consolidation CapeOx cycle. After preoperative treatment, TME with different adjuvant therapy types were performed in patients.ResultsWith treatment processing, 48 patients were excluded from the trial due to personal reasons and intolerance to treatment toxicities. Finally, there were 61 patients in arm A and 63 patients in arm B (70.9% vs. 73.2%). The 5-years DFS and OS didn’t show significant difference in two arms. However, the postoperative complications of arms A and B were 4.9% and 17.5% (P=0.027).ConclusionsSandwich therapy may lead more postoperative complications than conventional CRT, so that the safety should further research. Compared with conventional CRT, sandwich therapy doesn’t show significant advantage in survival.