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

September 20, 2010 updated by: National Cancer Center, Korea

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-767
        • Recruiting
        • Soonchunhyang University College of Medicine
        • Contact:
        • Principal Investigator:
          • Gyu Seok Cho, MD, PhD
      • Bucheon, Korea, Republic of
        • Recruiting
        • Catholic University Holy Family Hospital
        • Contact:
        • Principal Investigator:
          • Wook Kim, MD, PhD
      • Daegu, Korea, Republic of, 700-712
        • Recruiting
        • Keimyung University College of Medicine
        • Contact:
        • Principal Investigator:
          • Seung-Wan Ryu, MD, PhD
      • Pusan, Korea, Republic of, 602-715
        • Recruiting
        • Dong-A University College of Medicine
        • Principal Investigator:
          • Min Chan Kim, MD, PhD
        • Contact:
      • Seongnam, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Hyung-Ho Kim, MD, PhD
          • Phone Number: 82-31-787-7095
          • Email: hhkim@snubh.org
        • Principal Investigator:
          • Hyung-Ho Kim, MD, PhD
        • Sub-Investigator:
          • Do Joong Park, MD
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Hyuk-Joon Lee, MD, PhD
        • Sub-Investigator:
          • Han Kwang Yang, MD, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Tae Sung Sohn, MD
        • Principal Investigator:
          • Tae Sung Sohn, MD
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei University College of Medicine
        • Contact:
        • Principal Investigator:
          • Woo Jin Hyung, MD, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Catholic University Kangnam St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Kyo Young Song, MD, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Hospital
        • Contact:
          • Joo Ho Lee, MD
        • Principal Investigator:
          • Joo Ho Lee, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangnam Severance Hospital
        • Contact:
          • Seung Ho Choi, MD
        • Principal Investigator:
          • Seung Ho Choi, MD
      • Suwon, Korea, Republic of
        • Recruiting
        • St. Vincent's Hospital
        • Contact:
          • Hyung Min Jin, MD
        • Principal Investigator:
          • Hyung Min Jin, MD
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University College of Medicine
        • Contact:
        • Principal Investigator:
          • Sang-Uk Han, MD, PhD
      • Ulsan, Korea, Republic of
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Kyu Yeol Kim, MD
    • Chonbuk
      • Chonjoo, Chonbuk, Korea, Republic of
        • Recruiting
        • Chonbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Chan Young Kim, MD
    • Chungnam
      • Daejun, Chungnam, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Sang Il Lee, MD
        • Principal Investigator:
          • Sang IL Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
overall survival

Secondary Outcome Measures

Outcome Measure
quality of life
cost-effectiveness
disease-free survival
morbidity and mortality
inflammatory and immune response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Hyung-Ho Kim, MD, PhD, Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (Estimate)

March 27, 2007

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 20, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0520310-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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