We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Gastrectomy for Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01441336
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Laparoscopic Gastrectomy Procedure: Laparoscopic gastrectomy Phase 2

Detailed 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)


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Gastrectomy for Advanced Gastric Cancer
Study Start Date : November 2008
Primary Completion Date : July 2012
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Laparoscopic gastrectomy

Laparoscopic gastrectomy procedure:

D2 lymphadenectomy & total omentectomy in case of tumor with serosa exposure under laparoscopic exploration

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


Outcome Measures

Primary Outcome Measures :
  1. 3 year recurrence free survival [ Time Frame: Postoperative 3 year ]
    Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01441336


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyung-Ho Kim, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01441336     History of Changes
Other Study ID Numbers: SNUBHGS02
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases