3118 - President: A Randomised Phase III Trial of Preoperative Chemoradiation Versus Post Operative Chemoradiation for Locally Advanced Potential Resectable Gastric Cancer.

M. Zeng¹, V. Verma², and X. Luo³; ¹Cancer Center, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China, ²Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, ³Oncology Department , Chengdu Medical College, Chengdu, China

Purpose/Objective(s): In this article, we describe the President trial, which is a randomized phase III trial comparing control arm therapy of adjuvant chemoradiation with experimental arm therapy of preoperative chemoradiation plus chemotherapy. Materials/

Methods: Eligible patients with locally advanced (T3/4 N+M0) resectable adenocarcinoma of the stomach or gastroesophageal junction will be randomized to receive either preoperative chemoradiation therapy or adjuvant chemoradiation. In the preoperative chemoradiation arm, patients receive 1 cycle of chemo plus chemoradiation prior to surgery, and then following adjuvant chemotherapy for 2 cycles; in postoperative chemoradiation arm, patients receive 1 cycle of chemo before surgery and followed by chemoradiation and additional 2 cycle chemotherapy. Capecitabine and Oxaliplatin (CapOX) were administered before, during, and after radiotherapy. Radiotherapy was given to all local regional failure sites to a dose of 45 Gy in 25 fractions using IMRT.
Results: The trial is being conducted between 2016 to 2021 multiple centers, which provide a total sample size of 450 patients. The primary endpoint of the phase III trial is progression free survival, 2ndary endpoints are overall survival and R0 resection rate. The trial includes quality of surgery assurance program to invest the importance of D2 resection in the locally advanced gastric cancer.
Conclusion: President trial is a ClinicalTrial Register Trial NCT03223740. It addresses an important question that will help inform future standards for clinical practice in locally advanced potential resectable gastric cancer.