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Gastric CancerPhase 3KLASSNCT00452751

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

A Phase 3 study testing laparoscopy-assisted distal gastrectomy and open distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 16 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
laparoscopy-assisted distal gastrectomy and open distal gastrectomy
Type of treatment
Surgery or procedure
How many people
1,400 participants
Where
16 sitesSouth Korea
Study dates
Feb 2006to May 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pathologically proven gastric adenocarcinoma
  • age: 20 ~ 80 years
  • preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0
  • no history of other cancer
  • no history of chemotherapy or radiotherapy
  • written informed consent

Who cannot join

  • ASA >3
  • combined resection
  • total gastrectomy

Trial locations and contacts

16 sites in 1 country.

Hyung-Ho Kim, MD, PhD contact

82-31-787-7095

hhkim@snubh.org

16 sites in 1 country

South Korea16 sites, 16 recruiting

  • Soonchunhyang University College of Medicine

    Bucheon-si, 420-767

    Gyu Seok Cho, MD, PhD, 82-32-621-5114, gschogs@schbc.ac.kr

    Gyu Seok Cho, MD, PhD

    Recruiting

  • Catholic University Holy Family Hospital

    Bucheon-si

    Wook Kim, MD, PhD, 82-32-340-2114, kimwook@catholic.ac.kr

    Wook Kim, MD, PhD

    Recruiting

  • Chonbuk National University Hospital

    Chonjoo, Jeollabuk-do

    Chan Young Kim, MD, happyhill@chonbuk.ac.kr

    Chan Young Kim, MD

    Recruiting

  • Keimyung University College of Medicine

    Daegu, 700-712

    Seung-Wan Ryu, MD, PhD, 82-53-250-7114, gsman@dsmc.or.kr

    Seung-Wan Ryu, MD, PhD

    Recruiting

  • Chungnam National University Hospital

    Daejun, Chungcheongnam-do

    Sang Il Lee, MD

    Sang IL Lee, MD

    Recruiting

  • Dong-A University College of Medicine

    Pusan, 602-715

    Min Chan Kim, MD, PhD, 82-51-240-2000, mckim@donga.ac.kr

    Min Chan Kim, MD, PhD

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

    Hyung-Ho Kim, MD, PhD, 82-31-787-7095, hhkim@snubh.org

    Hyung-Ho Kim, MD, PhD

    Recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Hyuk-Joon Lee, MD, PhD, 82-2-2072-1957, appe98@snu.ac.kr

    Hyuk-Joon Lee, MD, PhD

    Recruiting

  • Yonsei University College of Medicine

    Seoul, 120-752

    Woo Jin Hyung, MD, PhD, 82-2-2227-0114, wjhyung@yumc.yonsei.ac.kr

    Woo Jin Hyung, MD, PhD

    Recruiting

  • Catholic University Kangnam St. Mary's Hospital

    Seoul

    Kyo Young Song, MD, PhD, 82-2-590-1114, skygs@catholic.ac.kr

    Kyo Young Song, MD, PhD

    Recruiting

  • Ewha Womans University Hospital

    Seoul

    Joo Ho Lee, MD

    Joo Ho Lee, MD

    Recruiting

  • Kangnam Severance Hospital

    Seoul

    Seung Ho Choi, MD

    Seung Ho Choi, MD

    Recruiting

  • Samsung Medical Center

    Seoul

    Tae Sung Sohn, MD

    Tae Sung Sohn, MD

    Recruiting

  • Ajou University College of Medicine

    Suwon

    Sang-Uk Han, MD, PhD, 82-31-219-5114, hansu@ajou.ac.kr

    Sang-Uk Han, MD, PhD

    Recruiting

  • St. Vincent's Hospital

    Suwon

    Hyung Min Jin, MD

    Hyung Min Jin, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Kyu Yeol Kim, MD, kim9107798@dreamwiz.com

    Kyu Yeol Kim, MD

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Gastric Cancer
Being tested
laparoscopy-assisted distal gastrectomy, open distal gastrectomy
Keywords
gastric cancer, laparoscopic surgery, survival, preoperative staging, morbidity, quality of life, acute inflammatory reaction, cost
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopy-assisted distal gastrectomyProcedure or surgery

  • open distal gastrectomyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

Secondary outcomes (5)

  1. disease-free survival

  2. morbidity and mortality

  3. quality of life

  4. inflammatory and immune response

  5. cost-effectiveness

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2007 (estimated)
  2. Study startFeb 2006
  3. Study completionMay 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452751
Sponsor's protocol ID
0520310-2
Acronym
KLASS
Status last verified
Sep 2010
First submitted
26 Mar 2007
Last updated
21 Sep 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim HH, Han SU, Kim MC, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01 Randomized Clinical Trial. JAMA Oncol. 2019 Apr 1;5(4):506-513. doi: 10.1001/jamaoncol.2018.6727.

    PubMed 30730546

  • Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.

    PubMed 26352529

  • Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01). J Korean Surg Soc. 2013 Feb;84(2):123-30. doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29.

    PubMed 23396494

  • Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.

    PubMed 20160637

  • Kim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.

    PubMed 18663532

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing laparoscopy-assisted distal gastrectomy and open distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyung-Ho Kim, MD, PhD (82-31-787-7095, hhkim@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452751, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2010.

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