Laparoscopic Gastrectomy for Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

Official title:

Laparoscopic Gastrectomy for Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441336
• Other study ID #: SNUBHGS02
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2011
• Last updated: January 6, 2017
• Start date: November 2008
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of LAG in the management of advanced gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for AGC.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Laparoscopic Gastrectomy
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic gastrectomy
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year recurrence free survival	Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.	Postoperative 3 year	Yes