20 Years
80 Years
Both
Advanced Gastric Cancer, Laparoscopic Gastrectomy
Trial Information
Prospective phase II clinical trial to evaluate technical and oncological safety of LG for
AGC
LG procedure for AGC:
D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic
exploration
Primary end point: 3 year disease free survival secondary end point: postoperative outcomes,
morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence
pattern
Study duration: 7 years(enrollment: 4year, follow-up: 3year)
Inclusion Criteria:
- Age 20-80
- informed consent
- no other malignancies
- cT2N0-cT3N2 according to JGCA 2nd edition
- ASA score<3
Exclusion Criteria:
- distant metastasis(P1 or M1) under laparoscopic exploration
- Conglomerated N2
- early gastric cancer in permanent pathologic report
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3 year recurrence free survival
Outcome Description:
Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.
Outcome Time Frame:
Postoperative 3 year
Safety Issue:
Yes
Authority:
Korea: Institutional Review Board
Study ID:
SNUBHGS02
NCT ID:
NCT01441336
Start Date:
November 2008
Completion Date:
May 2015
Related Keywords:
- Advanced Gastric Cancer
- Laparoscopic Gastrectomy
- Stomach Neoplasms
Name | Location |
|---|
