NCT00407186

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
788

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2007

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

11.9 years

First QC Date

December 1, 2006

Last Update Submit

October 9, 2017

Conditions

Gastric Cancer

Keywords

CRITICSgastric cancersurgeryadjuvantchemotherapychemoradiotherapycapecitabinecisplatinepirubicin

Outcome Measures

Primary Outcomes (1)

  • overall survival

    study duration

Secondary Outcomes (3)

  • disease-free survival

    study duration

  • toxicity

    study duration

  • health-related quality of life

    study duration

Study Arms (2)

1chemoradiotherapy

EXPERIMENTAL

5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.

Drug: cisplatin+capecitabineRadiation: radiotherapy

2chemotherapy

ACTIVE COMPARATOR

3 adjuvant courses epirubicin, cisplatin, capecitabine.

Drug: epirubicin+cisplatin+capecitabine

Interventions

cisplatin+capecitabineDRUG

cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.

1chemoradiotherapy
radiotherapyRADIATION

45 Gy in 25 fracions (5 days/week)

1chemoradiotherapy
epirubicin+cisplatin+capecitabineDRUG

3 courses q 3 w: epirubicin 50 mg/m2 (i.v., day 1), cisplatin 60 mg/m2 (i.v., day 1), capecitabine 1000 mg/m2 (b.i.d., oral, day 1-14)

2chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ib-IVa (no distant metastases) gastric cancer (histologically proven); tumor bulk in the stomach
  • WHO \< 2
  • Age ≥18 yrs
  • Operable gastric cancer
  • No prior abdominal radiotherapy or chemotherapy
  • Tumornegative laparoscopy when CT suggests peritoneal carcinomatosis
  • Start treatment within 10 working days after registration
  • Written informed consent

You may not qualify if:

  • T1N0 disease (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.
  • 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 cardiac disorders
  • Continuous use of immunosuppressive agents
  • Concurrent use of the antiviral agent sorivudine or chemically related analogues
  • Hearing loss \> CTC grade 1
  • Neurotoxicity \> CTC grade 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (8)

  • Quaas A, Biesma HD, Wagner AD, Verheij M, van Berge Henegouwen MI, Schoemig-Markiefka B, Pamuk A, Zander T, Siemanowski J, Sikorska K, Egthuijsen JMP, Meershoek-Klein Kranenbarg EM, van de Velde CJH, Buettner R, Alakus H, Cats A, Ylstra B, van Laarhoven HWM, van Grieken NCT. Microsatellite instability and sex differences in resectable gastric cancer - A pooled analysis of three European cohorts. Eur J Cancer. 2022 Sep;173:95-104. doi: 10.1016/j.ejca.2022.06.025. Epub 2022 Jul 18.

    PMID: 35863110DERIVED

  • Slagter AE, Vollebergh MA, Caspers IA, van Sandick JW, Sikorska K, Lind P, Nordsmark M, Putter H, Braak JPBM, Meershoek-Klein Kranenbarg E, van de Velde CJH, Jansen EPM, Cats A, van Laarhoven HWM, van Grieken NCT, Verheij M. Prognostic value of tumor markers and ctDNA in patients with resectable gastric cancer receiving perioperative treatment: results from the CRITICS trial. Gastric Cancer. 2022 Mar;25(2):401-410. doi: 10.1007/s10120-021-01258-6. Epub 2021 Oct 29.

    PMID: 34714423DERIVED

  • de Steur WO, van Amelsfoort RM, Hartgrink HH, Putter H, Meershoek-Klein Kranenbarg E, van Grieken NCT, van Sandick JW, Claassen YHM, Braak JPBM, Jansen EPM, Sikorska K, van Tinteren H, Walraven I, Lind P, Nordsmark M, van Berge Henegouwen MI, van Laarhoven HWM, Cats A, Verheij M, van de Velde CJH; CRITICS investigators. Adjuvant chemotherapy is superior to chemoradiation after D2 surgery for gastric cancer in the per-protocol analysis of the randomized CRITICS trial. Ann Oncol. 2021 Mar;32(3):360-367. doi: 10.1016/j.annonc.2020.11.004. Epub 2020 Nov 20.

    PMID: 33227408DERIVED

  • Slagter AE, Sikorska K, Grootscholten C, van Laarhoven HWM, Lind P, Nordsmark M, Meershoek-Klein Kranenbarg E, van de Velde CJH, van Grieken NCT, van Sandick JW, Jansen EPM, Verheij M, Cats A. Venous thromboembolism during preoperative chemotherapy in the CRITICS gastric cancer trial. Cancer Med. 2020 Sep;9(18):6609-6616. doi: 10.1002/cam4.3118. Epub 2020 Jul 31.

    PMID: 32735752DERIVED

  • Slagter AE, Tudela B, van Amelsfoort RM, Sikorska K, van Sandick JW, van de Velde CJH, van Grieken NCT, Lind P, Nordsmark M, Putter H, Hulshof MCCM, van Laarhoven HWM, Grootscholten C, Braak JPBM, Meershoek-Klein Kranenbarg E, Jansen EPM, Cats A, Verheij M. Older versus younger adults with gastric cancer receiving perioperative treatment: Results from the CRITICS trial. Eur J Cancer. 2020 May;130:146-154. doi: 10.1016/j.ejca.2020.02.008. Epub 2020 Mar 21.

    PMID: 32208351DERIVED

  • Cats A, Jansen EPM, van Grieken NCT, Sikorska K, Lind P, Nordsmark M, Meershoek-Klein Kranenbarg E, Boot H, Trip AK, Swellengrebel HAM, van Laarhoven HWM, Putter H, van Sandick JW, van Berge Henegouwen MI, Hartgrink HH, van Tinteren H, van de Velde CJH, Verheij M; CRITICS investigators. Chemotherapy versus chemoradiotherapy after surgery and preoperative chemotherapy for resectable gastric cancer (CRITICS): an international, open-label, randomised phase 3 trial. Lancet Oncol. 2018 May;19(5):616-628. doi: 10.1016/S1470-2045(18)30132-3. Epub 2018 Apr 9.

    PMID: 29650363DERIVED

  • Dikken JL, van Sandick JW, Maurits Swellengrebel HA, Lind PA, Putter H, Jansen EP, Boot H, van Grieken NC, van de Velde CJ, Verheij M, Cats A. Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS). BMC Cancer. 2011 Aug 2;11:329. doi: 10.1186/1471-2407-11-329.

    PMID: 21810227DERIVED

  • Jansen EPM, Boot H, Dubbelman R, Verheij M, Cats A. Postoperative chemoradiotherapy in gastric cancer--a phase I-II study of radiotherapy with dose escalation of weekly cisplatin and daily capecitabine chemotherapy. Ann Oncol. 2010 Mar;21(3):530-534. doi: 10.1093/annonc/mdp345. Epub 2009 Aug 18.

    PMID: 19690058DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Marcel Verheij, MD PhD

    Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2006

First Posted

December 4, 2006

Study Start

January 11, 2007

Primary Completion

December 1, 2018

Study Completion

December 1, 2025

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

NL(1)