Multicentric Randomised Trial for Resectable Gastric Cancer

Last updated: April 30, 2024
Sponsor: The Netherlands Cancer Institute
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

Docetaxel

Capecitabine

radiotherapy of gastric cancer

Clinical Study ID

NCT02931890
M15CRI
NL 55436.031.015
2015-004627-31
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to bein 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 lesionsand/or substantial free peritoneal fluid if any should be pathologically proven tumornegative
  • 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 thelast 6 months or > 5% over the last month, dietary intervention such as oralnutritional support or enteral tube feeding is mandatory

Exclusion

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-situcancer of the cervix uteri; in case of a previous other malignancy with a disease-freeperiod≥5 years, inclusion can be accepted after consultation of the principalinvestigator
  • Solitary functioning kidney that will be within the radiation field
  • Major surgery within 4 weeks prior to study treatment start, or lack of completerecovery from the effects of major surgery
  • Uncontrolled (bacterial) infections
  • Significant concomitant diseases preventing the safe administration of study drugs orlikely 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, suchas brivudine
  • Neurotoxicity > CTC grade 1
  • Pregnancy or breast feeding
  • Patients (M/F) with reproductive potential not implementing adequate contraceptivemeasures
  • Gastric or gastro-esophageal stent within radiation field

Study Design

Total Participants: 207
Treatment Group(s): 7
Primary Treatment: Docetaxel
Phase: 2
Study Start date:
December 21, 2017
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Medisch Centrum Leeuwarden

    Leeuwarden, Friesland 8901BR
    Netherlands

    Site Not Available

  • Radiotherapeutisch Instituut Friesland

    Leeuwarden, Friesland 8934AD
    Netherlands

    Site Not Available

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland 7334DZ
    Netherlands

    Site Not Available

  • Gelre Ziekenhuizen

    Zutphen, Gelderland 7207AE
    Netherlands

    Site Not Available

  • Zuyderland Medisch Centrum

    Sittard-Geleen, Limburg 6162 BG
    Netherlands

    Site Not Available

  • Viecuri Medisch Centrum

    Venlo, Limburg 5912 BL
    Netherlands

    Site Not Available

  • Elkerliek

    Deurne, Noord Brabant 5751 CB
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven, Noord Brabant 5602 ZA
    Netherlands

    Site Not Available

  • Maxima Medisch Centrum

    Eindhoven, Noord Brabant 5631 BM
    Netherlands

    Site Not Available

  • St. Anna Zorggroep

    Geldrop, Noord Brabant 5664 EH
    Netherlands

    Site Not Available

  • Elkerliek

    Helmond, Noord Brabant 5707 HA
    Netherlands

    Site Not Available

  • Instituut Verbeeten

    Tilburg, Noord Brabant 5022 GC
    Netherlands

    Site Not Available

  • Bernhoven

    Uden, Noord Brabant 5406 PT
    Netherlands

    Site Not Available

  • Maxima Medisch Centrum

    Veldhoven, Noord Brabant 5504 DB
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp, Noord-Holland 2000 AK
    Netherlands

    Site Not Available

  • Ziekenhuisgroep Twente

    Almelo, Overijssel 7609 PP
    Netherlands

    Site Not Available

  • Deventer Ziekenhuis

    Deventer, Overijssel 7416 SE
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, Overijssel 7512 KZ
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, Zuid Holland 2333 ZA
    Netherlands

    Site Not Available

  • Reinier de Graaf Gasthuis

    Delft, Zuid-Holland 2625 AD
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ
    Netherlands

    Site Not Available

  • Academisch Medisch Centrum

    Amsterdam, 1105AZ
    Netherlands

    Site Not Available

  • Netherlands Cancer Instituut

    Amsterdam, 1066CX
    Netherlands

    Site Not Available

  • Rijnstate

    Arnhem, 6815AD
    Netherlands

    Site Not Available

  • HAGA ziekenhuis

    Den Haag, 2545AA
    Netherlands

    Site Not Available

  • Ziekenhuis Gelderse Vallei

    Ede, 6716RP
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Ziekenhuis St Antonius

    Nieuwegein, 3435CM
    Netherlands

    Site Not Available

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg, 5022GC
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3508 GA
    Netherlands

    Site Not Available

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