Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial

Gastric Cancer Clinical Trial

— KLASS  

Official title:

Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00452751
• Other study ID #: 0520310-2
• Status: Recruiting
• Phase: Phase 3
• First received: March 26, 2007
• Last updated: September 20, 2010
• Start date: February 2006
• Est. completion date: May 2014

Study information

• Verified date: September 2010
• Source: National Cancer Center, Korea
• Contact: Hyung-Ho Kim, MD, PhD
• Phone: 82-31-787-7095
• Email: hhkim[@]snubh.org
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.

Description:

Recently, in technical aspects, almost all kinds of open gastric cancer surgeries can be reproduced laparoscopically. However, many controversies exist due to no evidence and no long-term results. There was no prospective multi-center large-scale randomized controlled trial in the world on the long-term outcome of laparoscopic gastric cancer surgery.

Korean Laparoscopic Gastrointestinal Surgery Study Group, therefore, proposed a multi-institutional prospective randomized trial on comparing laparoscopy-assisted versus open distal gastrectomy for gastric cancer (KLASS Trial) after the feasibility and validity of these procedures had been evaluated by analyzing retrospective multi-center large series.

This KLASS trial is supported by a grant for 2005 from the National R&D Program for Cancer Control, Ministry of Health & Welfare, Republic of Korea. Nine surgeons from 9 centers are participating in this trial. All the participants performed more than 50 cases of open and laparoscopic gastrectomies, respectively and their institutes had more than 80 cases of gastric cancer surgeries per year. Primary endpoint of this trial is to elucidate that there is no difference of overall and disease-free survivals between laparoscopic and open groups. The KLASS trial consists of 5 major subjects: comparison of 5-year overall and disease-free survivals, standardization of preoperative diagnosis, assessment of the quality of life, evaluation of postoperative inflammatory response and immune function, and cost-effectiveness. The KLASS trial will be able to validate and verify laparoscopic gastric cancer surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. pathologically proven gastric adenocarcinoma

2. age: 20 ~ 80 years

3. preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0

4. no history of other cancer

5. no history of chemotherapy or radiotherapy

6. written informed consent

Exclusion Criteria:

1. ASA >3

2. combined resection

3. total gastrectomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• laparoscopy-assisted distal gastrectomy

• open distal gastrectomy

Locations

Country	Name	City	State
Korea, Republic of	Catholic University Holy Family Hospital	Bucheon
Korea, Republic of	Soonchunhyang University College of Medicine	Bucheon
Korea, Republic of	Chonbuk National University Hospital	Chonjoo	Chonbuk
Korea, Republic of	Keimyung University College of Medicine	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejun	Chungnam
Korea, Republic of	Dong-A University College of Medicine	Pusan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Catholic University Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Ewha Womans University Hospital	Seoul
Korea, Republic of	Kangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul
Korea, Republic of	Ajou University College of Medicine	Suwon
Korea, Republic of	St. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival
Secondary	disease-free survival
Secondary	morbidity and mortality
Secondary	quality of life
Secondary	inflammatory and immune response
Secondary	cost-effectiveness