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Laparoscopic Gastrectomy for Advanced Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01441336
First received: September 25, 2011
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Advanced Gastric Cancer
Laparoscopic Gastrectomy
 Procedure: Laparoscopic gastrectomy
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

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


Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hyung-Ho Kim, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01441336     History of Changes
Other Study ID Numbers: SNUBHGS02
Study First Received: September 25, 2011
Last Updated: May 21, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013