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

October 9, 2017 updated by: Dutch Colorectal Cancer Group

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

788

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1chemoradiotherapy
5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.
Drug: cisplatin+capecitabine
cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.
Radiation: radiotherapy
45 Gy in 25 fracions (5 days/week)
Active Comparator: 2chemotherapy
3 adjuvant courses epirubicin, cisplatin, capecitabine.
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: study duration
study duration

Secondary Outcome Measures

Outcome Measure
Time Frame
toxicity
Time Frame: study duration
study duration
disease-free survival
Time Frame: study duration
study duration
health-related quality of life
Time Frame: study duration
study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dutch Colorectal Cancer Group

Collaborators

Roche Pharma AG
The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Marcel Verheij, MD PhD, Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2007

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 1, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRITICS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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