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Multicentric Randomised Trial for Resectable Gastric Cancer
Sponsor: The Netherlands Cancer Institute
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
Docetaxel
3 weekly course of docetaxel i.v in arm 1 and 2
Oxaliplatin
3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
Capecitabine
oral capecitabine in arm 1 and 2
gastrectomy
resection of gastric cancer after pre-operative chemotherapy for all arms
radiotherapy of gastric cancer
5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
Paclitaxel
5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
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