BMC Cancer (Jun 2019)

Study protocol of a randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma: PREACT

  • Xiaowen Liu,
  • Jiejie Jin,
  • Hong Cai,
  • Hua Huang,
  • Guangfa Zhao,
  • Ye Zhou,
  • Jianghong Wu,
  • Chunyan Du,
  • Ziwen Long,
  • Yantian Fang,
  • Mingze Ma,
  • Guichao Li,
  • Menglong Zhou,
  • Jiliang Yin,
  • Xiaodong Zhu,
  • Ji zhu,
  • Weiqi Sheng,
  • Dan Huang,
  • Hui Zhu,
  • Zhaozhen Zhang,
  • Qi Lu,
  • Li Xie,
  • Zhen Zhang,
  • Yanong Wang

DOI
https://doi.org/10.1186/s12885-019-5728-8
Journal volume & issue
Vol. 19, no. 1
pp. 1 – 6

Abstract

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Abstract Background The prognosis of patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma is still dismal. There are no standard treatment strategies for these patients. Multidisciplinary team (MDT) approach is a good choice for making a high-quality decision. Generally, MDT will recommend these patients to receive preoperative chemotherapy or preoperative chemoradiation based on all kinds of treatment guidelines. However, the preferred preoperative treatment is still not established. In order to solve this problem, we carry out this randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma. Methods Eligible patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma are randomized to receive preoperative chemoradiation or preoperative chemotherapy, followed by surgery and postoperative chemotherapy. In the preoperative chemoradiation arm (Pre-CRT), patients receive two cycles of S-1 and oxaliplatin (SOX), chemoradiation, then followed by surgery and three more cycles of SOX chemotherapy. In the preoperative chemotherapy arm (Pre-CT), patients receive three cycles of SOX, following surgery three more cycles of SOX are given. The primary endpoint of this trial is to verify that preoperative chemoradiation could significantly improve the 3-year disease free survival (DFS) of patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma compared to preoperative chemotherapy. Discussion The results from this trial will provide important information about whether preoperative chemoradiation could improve survival compared to preoperative chemotherapy among patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma. Trial registration ClinicalTrials.gov Identifier: NCT03013010. First posted January 6, 2017.

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