MedDataX Logo

Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)

NCT ID: NCT00407186

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

788 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-11

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The mainstay of curative treatment of gastric cancer is radical surgical dissection. Because most patients in the Western world present with advanced stages long term survival is found in about 25%, with local recurrences as part of treatment failure in up to 80% of cases. Studies examining the role of more extended lymph node dissections (D1 vs. D2), adjuvant radiotherapy or adjuvant chemotherapy did not result in a clinical relevant improvement of survival. In 2001 results of a South West Oncology group (SWOG) trial that randomized between surgery and surgery with chemoradiotherapy were published. This trial, that was hampered by suboptimal surgery (less than D1 in majority of patients) and radiotherapy (2D radiotherapy; 35% protocol deviations) showed an absolute increase in median survival of 9 months. More recently results of the MAGIC study, which randomized between surgery and surgery plus 6 perioperative courses of ECF chemotherapy, were presented. This regimen resulted in an absolute 5-year survival benefit of 13% and in a 10% higher resectability rate.

This phase III prospectively randomized study investigates whether chemoradiotherapy (45 Gy in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC (epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival in comparison with postoperative chemotherapy (3x ECC). Furthermore, toxicity of both treatment regimens will be explored.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CRITICS gastric cancer surgery adjuvant chemotherapy chemoradiotherapy capecitabine cisplatin epirubicin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1chemoradiotherapy

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

Group Type EXPERIMENTAL

cisplatin+capecitabine

Intervention Type DRUG

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

radiotherapy

Intervention Type RADIATION

45 Gy in 25 fracions (5 days/week)

2chemotherapy

3 adjuvant courses epirubicin, cisplatin, capecitabine.

Group Type ACTIVE_COMPARATOR

epirubicin+cisplatin+capecitabine

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cisplatin+capecitabine

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

Intervention Type DRUG

radiotherapy

45 Gy in 25 fracions (5 days/week)

Intervention Type RADIATION

epirubicin+cisplatin+capecitabine

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)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Dutch Colorectal Cancer Group

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marcel Verheij, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35863110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34714423 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33227408 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32735752 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32208351 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29650363 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21810227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19690058 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.dccg.nl

Dutch Colorectal Cancer Group

http://www.nki.nl

Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis (Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRITICS

Identifier Type: -

Identifier Source: org_study_id