A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

Phase 2 Completed 71 enrolled Chinese Academy of Medical Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.

Timeline

Start: 2014-01
Primary completion: 2016-12
Completion: 2017-12

Outcome

Missed primary endpoint

paper S-1-based NACRT did not improve the R0 resection rate PMID 35574368 ↗

Publications

Wang X, Zhao DB, Yang L, Chi Y, Zhao H, Jiang LM, Jiang J, Tang Y, Li N, Liu WY, Dou LZ, Zou SM, Xue LY, Ren JS, Tian YT, Che X, Guo CG, Bai XF, Sun YM, Wang SL, Song YW, Liu YP, Fang H, Li YX, Jin J. Preoperative Concurrent Chemoradiotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: Phase II Randomized Study. Front Oncol. 2022 Apr 29;12:870741. doi: 10.3389/fonc.2022.870741. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Subject	S-1	Small molecule	40 mg/m2	Oral
Subject	S-1	Small molecule	40 mg	Oral
Subject	S-1	Small molecule	60 mg	Oral