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Multicentric Randomised Trial for Resectable Gastric Cancer

NCT02931890 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2024-05-02

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Marcel Verheij, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2025-04-30
Completion
2029-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931890 on ClinicalTrials.gov