Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer
- 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.
Behavioral: conventional gastrectomy or radical lymph node dissection
|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.|
- We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.
|Study Start Date:||October 1993|
|Estimated Study Completion Date:||August 2004|
|Study Chair:||Chew-Wun Wu, Ph.D.||Taipei Veterans General Hospital, Taiwan|
|Principal Investigator:||Su-Shun Lo, M.D.||Taipei Veterans General Hospital, Taiwan|