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 ZhangEmail author and
Yanong WangEmail author

BMC Cancer201919:606

https://doi.org/10.1186/s12885-019-5728-8

Received: 20 March 2018
Accepted: 16 May 2019
Published: 20 June 2019

Open Peer Review reports

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.