Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer (KLASS-02-RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Ajou University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Sang-Uk Han, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01456598
First received: October 11, 2011
Last updated: July 11, 2012
Last verified: July 2012
  Purpose
  • It was confirmed that the laparoscopic surgery decreases the postoperative pain and reduces the recovery periods in the various surgical fields such as cholecystectomy and colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is applicable to malignant tumor according to the development of surgical techniques and medical instruments.
  • In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence.
  • In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results.
  • For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified.
  • In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.

Condition Intervention Phase
Gastric Cancer
Procedure: Laparoscopic gastrectomy
Procedure: Open gastrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Multicenter Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • 3 year disease free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    In terms of locally advanced gastric cancer, to examine the non-inferiority of disease free sur-vival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection


Secondary Outcome Measures:
  • Early postoperative complication [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Early postoperative complication is defined as the events which occurs with-in postoperative 21 days, extension of hospitalization and rehospitaliation. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name and date of on-set (postoperatively) and treatment for complication.

  • Postoperative mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    It is defined as the death within postoperative 90 days regardless of postoperative reason. If the patient is transferred to other medication institutes with impossible condition for revocery be-fore death, it is regarded as death.

  • Late postoperative complication [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Late postoperative complication is defined the events which occurs after postoperative 21 days. It is necessary to evaluate the complication. it is required to record complication name and date of on-set (postoperatively) and treatment for complication.

  • Postoperative recovery index [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Postoperatively, the examiner evaluates the patient's recovery condition (gas exhaust) once a day. Evaluation items for patient's recovery condition: record the meal process once a day and inquire the pain score (10-scored scale) and blood test results at postoperative 2 and 5 days.

  • Postoperative quality of life [ Time Frame: preoperative, 3 weeks, 12 months ] [ Designated as safety issue: No ]
    On preoperative, postoperative 3 weeks and postoperative 12 months, both EORTC-C30 and STO22 are analyzed with quality of life by following methods. In case of EORTC-C30, the analysis is undergone by classifying into 5 functional scales (physical, role, emotional, cognitive, and social fungtioning), 3 symptom scales (fatigue, pain and nausea, and vomiting), 1 global health status and 6 single items.

  • 3 years overall survival [ Time Frame: 3 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months ] [ Designated as safety issue: No ]
    As one of the secondary endpoints, the overall survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection


Estimated Enrollment: 1050
Study Start Date: October 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic gastrectomy
Laparoscopic subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
Procedure: Laparoscopic gastrectomy
  • After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen.
  • The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection
  • After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view.
  • As the reconstruction, one of the techniques among Billroth type I, Billroth type II and Roux en Y is applied and there is no limitation on use of appliance.
Other Names:
  • Group A
  • LDG
Active Comparator: Open gastrectomy
Open subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.
Procedure: Open gastrectomy
  • After laparotomy, the possibility of surgery can be considered by examining inside of abdomen.
  • The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection
  • After lymph node dissection, one of the techniques among Billroth type I, Billroth type II and Roux en Y is applied and there is no limitation on use of appliance.
Other Names:
  • Group B
  • ODG

Detailed Description:

Participating Surgeons

  • Prior to this clinical trial, only the surgeons who are considered to have the standardization by participating the assignment entitled with "KLASS-02-QC: Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial"(ClinicalTrials.gov No: NCT01283893).

Patients Registration

  • It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
  • After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Ajou University clinical trial center.

Randomization

  • The registration randomization should be done with 1:1 ratio for each researcher.
  • Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.

Procedure

  • Operations are performed according to the allocated group.

Adjuvant Treatment

  • If it is under Stage II and Stage III in the final postoperative pathology, the adjuvant chemotherapy based on 5-FU.

Evaluation of efficacy and safety

  • 3-year disease free survival rate and overall survival rate of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
  • Analysis of recovery after laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
  • Postoperative complications of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection within postoperative 3 weeks and later.
  • The quality of life at preoperative, postoperative 25 days and 1 years using recovery index such as recovery of postoperative intestinal hypermotility, meals and duration of hospitalization, EORTC-C30 and STO22 questionnaire between the patients who underwent laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient from over 20 years to under 80 years
  • The patient with the capability for ECOG (Eastern Cooperative Oncology Group performance status) is ranged between 0 and 1
  • The patient included between ASA score (American society of anesthesiology) class I and III
  • The patient who is diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
  • The patient who is diagnosed as locally advanced gastric cancer with the suspicious infiltration of over muscular layer without infiltration on adjacent organs, and without or with lymph node metastasis limited to perigastric or around stomach left gastric artery at the preoperative examination.
  • The patient who is suitable for subtotal resection in the preoperative examination
  • The patient who is fully explained about purpose of trial and contents prior to the participation into this study and signed on the informed consent approved by Institutional Review Board according to own opinion

Exclusion Criteria:

  • The patient who shows distant metastasis under preoperative examination
  • The patient with medical history for gastrectomy in the past
  • The patient with complication (complete obstruction and perforation) by gastric cancer
  • The patient who undergoes anticancer or radiologic therapy prior to the operation or who undergoes endoscopic submucous dissection for currently diagnosed gastric cancer
  • The patient who undergoes surgery or anti-cancer radiologic therapy for primary cancer within 5 years
  • Vulnerable patients (lack of capacity for decision making, pregnant women (or under planning))
  • The patient who has participated into another clinical trial within recent 6 months or who is participating into another trial
  • The patient with double cancer of activity and synchronization
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456598

Contacts
Contact: Hoon Hur, M.D., Ph.D. +82-31-219-4384 hhcmc75@naver.com
Contact: Yun-Kyoung Kim, Nr. +82-31-219-4467 forsake326@ajou.ac.kr

Locations
Korea, Republic of
Department of Surgery , SOON CHUN HYANG UNIVESITY HOSPITAL Recruiting
Bucheon, Korea, Republic of
Contact: Gyu Seok Cho, M.D.,Ph.D.    +82-32-621-5814    gschogs@schmc.ac.kr   
Principal Investigator: Gyu Seok Kim, M.D.,Ph.D.         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Seungwan Ryu, M.D.,Ph.D.    +82-53-250-8322    gsman@dsmc.or.kr   
Principal Investigator: Seungwan Ryu, M.D.,Ph.D.         
Chonnam National University Hwasun Hospital Recruiting
Hwasun-gun, Korea, Republic of, 519-809
Contact: Young Kyu Park, M.D., Ph.D.    +61-379-7114    parkyk@jnu.ac.kr   
Principal Investigator: Young Kyu Park, M.D., Ph.D.         
Sub-Investigator: Seong Yeop Ryu, M.D.         
Incheon St, Mary's Hostpial, The Catholic University of Korea Recruiting
Incheon, Korea, Republic of, 403-720
Contact: Jin Jo Kim, M.D.    +82-1544-9004    kjj@catholic.ac.kr   
Principal Investigator: Jin Jo Kim, M.D.         
Dong-A University Hospital Recruiting
Pusan, Korea, Republic of, 602-715
Contact: Min Chan Kim, M.D., Ph.D.    +82-51-240-2000    mckim@donga.ac.kr   
Principal Investigator: Min Chan Kim, M.D., Ph.D.         
Department of Surgery, Seoul National University BUNDANG Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Hyung-ho Kim, M.D.,Ph.D.    +82-31-787-6163    hhkim@snubh.org   
Sub-Investigator: Do-joong Park, M.D.,Ph.D.         
Principal Investigator: hyung-ho Kim, M.D.,Ph.D.         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woo Jin Hyung, M.D., Ph.D.    +82-2-2227-0114    wjhyung@yumc.yonsei.ac.kr   
Principal Investigator: Woo Jin Hyung, M.D., Ph.D.         
Sub-Investigator: Hyoung-Il Kim, M.D.         
Sub-Investigator: Ji Yeong An, M.D.         
Department of Surgery, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Hyuk-Joon Lee, M.D., Ph.D.    +82-2-2072-1957    appe98@snu.ac.kr   
Principal Investigator: Hyuk-Joon Lee, M.D., Ph.D.         
Sub-Investigator: Han Kwang Yang, M.D., Ph.D.         
Yeoeuido St. Mary's Hospital, The Catholic University of Korea Recruiting
Seoul, Korea, Republic of, 150-713
Contact: Wook Kim, M.D., Ph.D.    +82-1661-7575    kimwook@catholic.ac.kr   
Principal Investigator: Wook Kim, M.D., Ph.D.         
Department of surgery, GANGNAM SEVERANCE HOSPITAL Recruiting
Seoul, Korea, Republic of
Contact: Jong Won Kim, M.D.,Ph.D.    +82-2-2019-3600    DRHOLY@YUHS.AC   
Principal Investigator: Jong Won Kim, M.D.,Ph.D.         
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-749
Contact: Sang-Uk Han, M.D., Ph.D.    +82-31-219-5200    hansu@ajou.ac.kr   
Principal Investigator: Sang-Uk Han, M.D., Ph.D.         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: San-Uk Han, M.D., Ph.D. Department of Surgery, Ajou University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Sang-Uk Han, Professor, Department of Surgery, Ajou University School of Medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01456598     History of Changes
Other Study ID Numbers: AJIRB-MED-MDB-11-233
Study First Received: October 11, 2011
Last Updated: July 11, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
Stomach neoplasm
Laparoscopy

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 September 18, 2014