NCT02931890

Multicentric Randomised Trial for Resectable Gastric Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts: * Preoperative treatment is associated with better patient compliance than postoperative regimens * Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections * Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	3 weekly course of docetaxel i.v in arm 1 and 2
DRUG	Oxaliplatin	3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
DRUG	Capecitabine	oral capecitabine in arm 1 and 2
PROCEDURE	gastrectomy	resection of gastric cancer after pre-operative chemotherapy for all arms
RADIATION	radiotherapy of gastric cancer	5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
DRUG	Paclitaxel	5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
DRUG	Carboplatin	5 weeks of carboplatin i.v once a week (in arm 2 and 3)

Timeline

• Start date: 2017-12-21
• Primary completion: 2025-04-01
• Completion: 2029-03-01
• First posted: 2016-10-13
• Last updated: 2024-05-02

Locations

28 sites across 1 country: Netherlands