Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT00260884|
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : December 2, 2005
- 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 or disease||Intervention/treatment||Phase|
|Gastric Cancer||Behavioral: conventional gastrectomy or radical lymph node dissection||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 1993|
|Estimated Study Completion Date :||August 2004|
- We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.
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
|Study Chair:||Chew-Wun Wu, Ph.D.||Taipei Veterans General Hospital, Taiwan|
|Principal Investigator:||Su-Shun Lo, M.D.||Taipei Veterans General Hospital, Taiwan|