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 |