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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Dutch Colorectal Cancer Group.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Netherlands Cancer Institute
Roche Pharma AG
Information provided by:
Dutch Colorectal Cancer Group
ClinicalTrials.gov Identifier:
NCT00407186
First received: December 1, 2006
Last updated: August 27, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin+capecitabine
Radiation: radiotherapy
Drug: epirubicin+cisplatin+capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Dutch Colorectal Cancer Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease-free survival [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
  • health-related quality of life [ Time Frame: study duration ] [ Designated as safety issue: No ]

Estimated Enrollment: 788
Study Start Date: December 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407186

Contacts
Contact: Marcel Verheij, MD PhD 020-5122124 rsc@rsconsultancy.nl
Contact: Raymond J. Schmidt, MD 0575-441001 rsc@rsconsultancy.nl

Locations
Netherlands
Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Marcel Verheij, MD PhD    020-5122124    m.verheij@nki.nl   
Contact: Annemieke    020-5122566    a.cats@nki.nl   
Principal Investigator: Marcel Verheij, MD PhD         
Sponsors and Collaborators
Dutch Colorectal Cancer Group
The Netherlands Cancer Institute
Roche Pharma AG
Investigators
Principal Investigator: Marcel Verheij, MD PhD Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis
  More Information

Additional Information:
No publications provided by Dutch Colorectal Cancer Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. Verheij MD PhD, DCCG
ClinicalTrials.gov Identifier: NCT00407186     History of Changes
Other Study ID Numbers: CRITICS
Study First Received: December 1, 2006
Last Updated: August 27, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Dutch Colorectal Cancer Group:
CRITICS
gastric cancer
surgery
adjuvant
chemotherapy
chemoradiotherapy
capecitabine
cisplatin
epirubicin

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Cisplatin
Epirubicin
Fluorouracil
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014