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Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

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ClinicalTrials.gov Identifier: NCT03385018
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE April 5, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
3 year relapse-free survival [ Time Frame: 3 years after surgery ]
Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery. The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation. The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up. The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03385018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • 3 year overall survival rate [ Time Frame: 3 years after surgery ]
  • 5 year relapse-free and overall survival [ Time Frame: 5 years after surgery ]
  • Morbidity (early period) [ Time Frame: from Operation day until POD 21 ]
  • Morbidity (late period) [ Time Frame: from POD (Post-Operative Day) 22 until 5 years after surgery ]
  • Mortality [ Time Frame: at POD 30 ]
    death with any cause
  • Mortality [ Time Frame: at POD 90 ]
    death with any cause
  • Quality of life(EORTC QLQ-C30) [ Time Frame: at POD 21 ]
    Quality of life measured by EORTC QLQ-C30(Version 3) The questionnaire was designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life).
  • Quality of life(EORTC QLC STO22) [ Time Frame: at POD 21 ]
    Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).
  • Quality of life(EORTC QLQ-C30) [ Time Frame: 3 months after surgery ]
    Quality of life measured by EORTC QLQ-C30(Version 3)
  • Quality of life(EORTC QLC STO22) [ Time Frame: 3 months after surgery ]
    Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).
  • Quality of life(EORTC QLQ-C30) [ Time Frame: 12 months after surgery ]
    Quality of life measured by EORTC QLQ-C30(Version 3)
  • Quality of life(EORTC QLC STO22) [ Time Frame: 12 months after surgery ]
    Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
  • 3 year overall survival rate [ Time Frame: 3 years after surgery ]
  • 5 year relapse-free and overall survival [ Time Frame: 5 years after surgery ]
  • Morbidity (early period) [ Time Frame: from Operation day until POD 21 ]
  • Morbidity (late period) [ Time Frame: from POD (Post-Operative Day) 22 until 5 years after surgery ]
  • Mortality [ Time Frame: at POD 30 ]
    death with any cause
  • Mortality [ Time Frame: at POD 90 ]
    death with any cause
  • Quality of life [ Time Frame: at POD 21 ]
    Quality of life measured by EORTC QLQ-C30(Version 3)
  • Quality of life [ Time Frame: at POD 21 ]
    Quality of life measured by . EORTC QLC STO22
  • Quality of life [ Time Frame: 3 months after surgery ]
    Quality of life measured by EORTC QLQ-C30(Version 3)
  • Quality of life [ Time Frame: 3 months after surgery ]
    Quality of life measured by . EORTC QLC STO22
  • Quality of life [ Time Frame: 12 months after surgery ]
    Quality of life measured by EORTC QLQ-C30(Version 3)
  • Quality of life [ Time Frame: 12 months after surgery ]
    Quality of life measured by EORTC QLC STO22
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Official Title  ICMJE Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Brief Summary

Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.

Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.

Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2-arm randomized controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
    • Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach
    • The number of trocars is 6 or less
    • Roux-en-Y esophagojejunostomy with any stapling method
    • Enough(negative) margin from tumor
    • LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
    • Washing cytology
    • Frozen biopsy for surgical margin at surgeons discretion
    • Complete omentectomy for grossly serosa-involved tumor
    • Combined organ resection only in cholecystectomy and splenectomy
    • Indwelling nasogastric tube and drainage catheter at surgeons discretion
    • D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection
  • Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
    • Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach
    • Roux-en-Y esophagojejunostomy with any stapling method
    • Enough(negative) margin from tumor
    • LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
    • Washing cytology
    • Frozen biopsy for surgical margin at surgeons discretion
    • Complete omentectomy for grossly serosa-involved tumor
    • Indwelling nasogastric tube and drainage catheter at surgeons discretion
    • D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection
Study Arms  ICMJE
  • Experimental: Laparoscopic group
    Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection
    Intervention: Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
  • Active Comparator: Open group
    Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection
    Intervention: Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2017)
772
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2027
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are over 20 and below 80 years old
  • Patients who have performance status of ECOG 0 or 1
  • Patients with American Society of Anesthesiology score of class I to III
  • Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
  • Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
  • Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 ~ cT4a)
  • Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 ~ cN2)
  • Patients who agree with participating in the clinical study with informed consents
  • Patients who can be followed for at least 3 years after study enrollment

Exclusion Criteria:

  • Patients who have possibility of distant metastasis in preoperative studies
  • Patients who have history of gastric resection with any cause
  • Patients who have complications (bleeding or obstruction) of gastric cancer
  • Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
  • Patients who are diagnosed and treated with other malignancies within 5 years
  • Vulnerable patients
  • Patients who participating or participated in other clinical trial within 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Woo Jin Hyung, MD, PhD +82-2-2228-2100 wjhyung@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03385018
Other Study ID Numbers  ICMJE 4-2017-0940
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP