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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

NCT02289547.

Trial name or title Randomized phase 3 study of XELOX (capecitabine plus oxaliplatin) followed by maintenance capecitabine or observation in participants with advanced gastric adenocarcinoma
Methods Multicentre RCT
2 arms
Phase 3
Allocation: Randomised
Intervention Model: Parallel assignment
Masking: Open‐label
Primary Purpose: Treatment
Participants N = 184 advanced or recurrent gastric cancer, age ≥18 years, HER‐2 negative, with more than stable disease after 6 cycles 1st line of XELOX chemotherapy (objective response, non‐complete response/non‐progressive disease in cases of non‐measurable disease before XELOX chemotherapy)
Interventions Arm A : Capecitabine: capecitabine 1000 mg/m² twice a day D1‐14, repeated at 3 weeks
Arm B : Observation
Outcomes Progression‐free survival, overall survival, quality of life (as measured by QLQ‐c30 and STO‐22), Toxicity profile
Starting date January 2015
Contact information Byoungyong Shim: shimby@catholic.ac.kr; Ho Jung An:
Notes Sponsor: The Catholic University of Korea