Cancer types
  • Digestive tract
Title of study
A multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery vs. neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery vs. neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer
Version Number
Approval Date 
3.1, 30 March 2018
Short Title
Critics II
Study site
Principle Investigator
Prof. Dr. M. Verheij, radiation oncologist
Investigator Maastro
dr J. Buijsen
Sponsor
Trial registry
Objectives 

• To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer
• To assess time to event of all treatment arms
• To assess which preoperative regimen provides superior time‐to‐recurrence (TTR)
• To assess which preoperative regimen is most feasible, based on toxicity, pCR and R0 resection rates
• To assess the toxicity profile of all treatment arms
• To document surgical morbidity, including incidence of anastomotic leakage
• To determine the pCR rates of all treatment arms
• To determine the R0 resection rates of all treatment arms
• To determine the response rate (RR) of all treatment arms  To determine the OS of all treatment arms
• To identify which preoperative regimen (CRITICS‐II) will be compared with the new standard treatment (CRITICS‐I) in a next phase III trial Explorative objectives
• To assess the relationship of histopathological parameters with clinical outcome parameters
• To identify biomarkers that predict clinical outcome and response to treatment
• To identify genomic changes in tumour‐derived DNA circulating in plasma
• To compare functional outcomes after preoperative treatment and surgery

Primary Endpoint 

Event‐free survival at 1 year after randomisation (events: local recurrence, regional recurrence, local‐regional recurrence or progression, distant recurrence, or death from any cause)

Secondary Endpoints