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Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer

This study has been completed.
Sponsor:
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00260884
First received: December 1, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose
  • OBJECTIVES To determine in a prospective randomized clinical trial, the effect of extended lymph node dissection (R3 gastrectomy) versus conventional surgery (R0/1 gastrectomy) on tumor recurrence and survival in Chinese patients with advanced cancer of the stomach (adenocarcinoma invasion beyond submucosa).
  • STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival. The log-rank test will be used as analytic method on disease-free survival and overall durvival. The follow-up time after treatment is five years.

Previous experience provides an estimation of a 20% 5-year survival rate with conventional surgery for gastric cancer. Assuming that this new treatment (radical surgery) may increase the 5-year survival rate to 40%, we estimate that 118 evaluable patients are required to detected a significance at a of 0.05 level and power of 0.8 using a one tailed test.

We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.


Condition Intervention Phase
Gastric Cancer
 Behavioral: conventional gastrectomy or radical lymph node dissection
 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: Phase III Study of the Effect of Radical Gastric Surgery Versus Conventional Surgery on Recurrence and Survival in Patients With Advanced Stage Gastric Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.

Estimated Enrollment: 220
Study Start Date: October 1993
Estimated Study Completion Date: August 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

  • Inclusion Criteria:

    1. Patients with histologically proven adenocarcinoma of the stomach.
    2. No clinical early stage stomach cancer (mucosa or submucosal invasion only).
    3. No esophageal invasion.
    4. No distant metastatic disease.
    5. No para-aortic, macrolymphadenopathy
    6. No N3, macrolymphadenopathy
    7. Suitable for gastric surgery with curative intent.
    8. Medically fit for surgery.
    9. No emergency resection required.
    10. No previous gastrectomy.
    11. Not older than 75 years.
    12. Signed informed consent form.
    13. No previous or concomitant other cancer.

  • Exclusion Criteria:

    1. Patients is not adenocarcinoma of the stomach.
    2. distant metastatic disease.
    3. previous gastrectomy.
    4. older than 75 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260884

Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
Study Chair: Chew-Wun Wu, Ph.D. Taipei Veterans General Hospital,Taiwan
Principal Investigator: Su-Shun Lo, M.D. Taipei Veterans General Hospital,Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260884     History of Changes
Other Study ID Numbers: A1293
Study First Received: December 1, 2005
Last Updated: December 1, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 23, 2013