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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00260884
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
National Health Research Institutes, Taiwan
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00260884     History of Changes
Other Study ID Numbers: A1293
First Submitted: December 1, 2005
First Posted: December 2, 2005
Last Update Posted: December 9, 2005
Last Verified: December 2005

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