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

NCT00260884 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2005-12-02

No results posted yet for this study

Summary

* 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.

Conditions

Interventions

BEHAVIORAL

conventional gastrectomy or radical lymph node dissection

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Chew-Wun Wu, Ph.D. · Taipei Veterans General Hospital, Taiwan

  • Su-Shun Lo, M.D. · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1993-10-31
Completion
2004-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260884 on ClinicalTrials.gov