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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407186
First Posted: December 4, 2006
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Netherlands Cancer Institute
Roche Pharma AG
Information provided by (Responsible Party):
Dutch Colorectal Cancer Group
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • disease-free survival [ Time Frame: study duration ]
  • toxicity [ Time Frame: study duration ]
  • health-related quality of life [ Time Frame: study duration ]

Enrollment: 788
Actual Study Start Date: January 11, 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407186


Locations
Netherlands
Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dutch Colorectal Cancer Group
ClinicalTrials.gov Identifier: NCT00407186     History of Changes
Other Study ID Numbers: CRITICS
First Submitted: December 1, 2006
First Posted: December 4, 2006
Last Update Posted: October 10, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Capecitabine
Epirubicin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors