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Clinical Trials in the Netherlands / NCT02931890
Active, not recruiting Phase 2

Multicentric Randomised Trial for Resectable Gastric Cancer

NCT02931890 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2017-12-21
Last updated
2024-05-02

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

Docetaxel →Oxaliplatin →Capecitabine →gastrectomyradiotherapy of gastric cancerPaclitaxel →Carboplatin →

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)

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to be in the stomach but may involve gastro-oesophageal junction * WHO \< 2 * Age ≥ 18 yrs * Resectable adenocarcinoma of the stomach or gastro-oesophageal junction * No prior abdominal radiotherapy * Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l, thrombocytes ≥100x109/l * Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN, alkaline phosphatase and ASAT/ALAT ≤ 3x ULN * At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesions and/or substantial free peritoneal fluid if any should be pathologically proven tumor negative * Written informed consent * Expected adequacy of follow-up * Caloric intake≥1500 kcal/day, verified by a dietician before registration. * if caloric intake is \< 1500 kcal/day or if bodyweight has decreased \> 10% over the last 6 months or \> 5% over the last month, dietary intervention such as oral nutritional support or enteral tube feeding is mandatory Exclusion Criteria: * T1N0 disease (assessed by endoscopic ultrasound) * Distant metastases * Inoperable patients; due to technical surgery-related factors or general condition * Previous malignancy, except adequately treated non-melanoma skin cancer or in-situ cancer of the cervix uteri; in case of a previous other malignancy with a disease-free period≥5 years, inclusion can be accepted after consultation of the principal investigator * Solitary functioning kidney that will be within the radiation field * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery * Uncontrolled (bacterial) infections * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias * Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednison * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine * Neurotoxicity \> CTC grade 1 * Pregnancy or breast feeding * Patients (M/F) with reproductive potential not implementing adequate contraceptive measures * Gastric or gastro-esophageal stent within radiation field

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Zuyderland Medisch Centrum Sittard-Geleen Limburg
Viecuri Medisch Centrum Venlo Limburg
Elkerliek Deurne North Brabant
Catharina Ziekenhuis Eindhoven North Brabant
Maxima Medisch Centrum Eindhoven North Brabant
St. Anna Zorggroep Geldrop North Brabant
Elkerliek Helmond North Brabant
Instituut Verbeeten Tilburg North Brabant
Bernhoven Uden North Brabant
Maxima Medisch Centrum Veldhoven North Brabant
Spaarne Gasthuis Hoofddorp North Holland
Ziekenhuisgroep Twente Almelo Overijssel
Deventer Ziekenhuis Deventer Overijssel
Medisch Spectrum Twente Enschede Overijssel
Medisch Centrum Leeuwarden Leeuwarden Provincie Friesland
Radiotherapeutisch Instituut Friesland Leeuwarden Provincie Friesland
Reinier de Graaf Gasthuis Delft South Holland
Leids Universitair Medisch Centrum Leiden South Holland
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

More The Netherlands Cancer Institute trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02931890 on ClinicalTrials.gov ↗ ← All trials in the Netherlands