History of Changes for Study: NCT00407186

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

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Study Record Versions

Version	Submitted Date	Changes
1	December 1, 2006	None (earliest Version on record)
2	June 26, 2007	Study Status, Study Design and Oversight
3	September 5, 2008	Arms and Interventions, Study Status, Outcome Measures, Eligibility and Sponsor/Collaborators
4	November 11, 2009	Sponsor/Collaborators, Study Status and Study Identification
5	August 27, 2011	Study Status
6	October 9, 2017	Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CRITICS
Brief Title:	Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)
Official Title:	A Multicenter Randomized Phase III Trial of Neo-Adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study)
Secondary IDs:

Study Status


Record Verification:	December 2006
Overall Status:	Recruiting
Study Start:	December 2006
Primary Completion:
Study Completion:	December 2013

First Submitted:	December 1, 2006
First Submitted that Met QC Criteria:	December 1, 2006
First Posted:	December 4, 2006 [Estimate]

Last Update Submitted that Met QC Criteria:	December 1, 2006
Last Update Posted:	December 4, 2006 [Estimate]

Sponsor/Collaborators


Sponsor:	Dutch Colorectal Cancer Group
Responsible Party:
Collaborators:	The Netherlands Cancer Institute Hoffmann-La Roche

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:

Study Description

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.

Detailed Description:

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


Conditions:	Gastric Cancer
Keywords:	CRITICS gastric cancer surgery adjuvant chemotherapy chemoradiotherapy capecitabine cisplatin epirubicin

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	788

Arms and Interventions


Intervention Details:
	Drug: epirubicin
	Drug: cisplatin
	Drug: capecitabine
	Procedure: radiotherapy

Outcome Measures


Primary Outcome Measures:
1.	overall survival
Secondary Outcome Measures:
1.	disease-free survival
2.	toxicity
3.	health-related quality of life

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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

Contacts/Locations


Central Contact Person:	Marcel Verheij, MD PhD Telephone: 020-5122124 Email: rsc@rsconsultancy.nl
Central Contact Backup:	Raymond J. Schmidt, MD Telephone: 0575-441001 Email: rsc@rsconsultancy.nl
Study Officials:	Marcel Verheij, MD PhD Principal Investigator Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis
Locations:	Netherlands
	Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis [Recruiting] Amsterdam, Netherlands, 1066 CX Contact:Contact: Marcel Verheij, MD PhD 020-5122124 m.verheij@nki.nl Contact:Contact: Annemieke 020-5122566 a.cats@nki.nl Contact:Principal Investigator: Marcel Verheij, MD PhD

IPDSharing


Plan to Share IPD:

References


Links:	URL: http://www.dccg.nl Description: Dutch Colorectal Cancer Group
	URL: http://www.nki.nl Description: Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis (Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital)
Available IPD/Information: