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)
Event-Free survival — 1 year Event-free survival will be measured by clinical outcome and CT-scan
Trial sites (28)
Facility
City
Region
Status
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
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.
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