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ACTIVE NOT RECRUITING
NCT02931890
PHASE2

Multicentric Randomised Trial for Resectable Gastric Cancer

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2017-12-21

Completion Date

2029-03

Last Updated

2024-05-02

Healthy Volunteers

No

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)

Locations (28)

Zuyderland Medisch Centrum

Sittard-Geleen, Limburg, Netherlands

Viecuri Medisch Centrum

Venlo, Limburg, Netherlands

Elkerliek

Deurne, North Brabant, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Maxima Medisch Centrum

Eindhoven, North Brabant, Netherlands

St. Anna Zorggroep

Geldrop, North Brabant, Netherlands

Elkerliek

Helmond, North Brabant, Netherlands

Instituut Verbeeten

Tilburg, North Brabant, Netherlands

Bernhoven

Uden, North Brabant, Netherlands

Maxima Medisch Centrum

Veldhoven, North Brabant, Netherlands

Spaarne Gasthuis

Hoofddorp, North Holland, Netherlands

Ziekenhuisgroep Twente

Almelo, Overijssel, Netherlands

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Radiotherapeutisch Instituut Friesland

Leeuwarden, Provincie Friesland, Netherlands

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Netherlands Cancer Instituut

Amsterdam, Netherlands

Academisch Medisch Centrum

Amsterdam, Netherlands

Rijnstate

Arnhem, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Ziekenhuis St Antonius

Nieuwegein, Netherlands

HAGA ziekenhuis

The Hague, Netherlands

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands