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

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.

Neo-adjuvant radiation therapy provides a survival advantage in T3-T4 nodal positive gastric and gastroesophageal junction adenocarcinoma: a SEER database analysis

“…CRITICS-II [ 8 ] and TOPGEAR [ 9 ] studies are actively investigating the effects of neo-adjuvant radiotherapy (NRT) in patients with stomach adenocarcinoma; the safety of preoperative chemoradiation has been proven according to interim analysis of preliminary results from TOPGEAR trial [ 10 ]. In China, two phase III RCTs, PREACT study [ 11 ] and NEO-CRAG (registration number NCT01815853), are currently underway to provide more evidence for efficacy of preoperative chemoradiation compared with preoperative chemotherapy in locally advanced gastric and GEJ adenocarcinoma.…”

Neoadjuvant chemoradiotherapy followed by laparoscopic distal gastrectomy in advanced gastric cancer: A case report and review of literature

“…The depiction of NACRT is restricted by the scant number of clinical trials with high levels of evidence. As we reviewed the phase II/III studies of NACRT (not for esophagogastric junction or esophagus) on gastric cancer following curative gastrectomy from the past 20 years through a search of the PubMed, MEDLINE and EMBASE (language was limited to English, Table 1 and 2 )[ 21 - 34 ], to date only Skoropad et al [ 32 ] reported a complete phase III trial result with no significant findings in 10-year overall survival (NACRT + Surgery vs Surgery, 32% vs 18%). However, neither the dose nor the technique in target delineation met the current standard.…”

Development of a Quantitative Diagnostic Criterion for Gastric Linitis Plastica: Findings From a Large Single-Institutional Study

“…Preoperative chemotherapy is mostly that patients receive two or three cycles of S-1 and oxaliplatin (SOX, lasting 21 days) before surgery in our center. Chemoradiation is mostly that patients receive two cycles of SOX plus 45 Gy radiation administered concurrently with S-1 before surgery in our center (24).…”