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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Yonsei University College of Medicine, Seoul, KoreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic group

Open group

Arm Description

Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection

Outcomes

Primary Outcome Measures

3 year relapse-free survival
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".

Secondary Outcome Measures

3 year overall survival rate
5 year relapse-free and overall survival
Morbidity (early period)
Morbidity (late period)
Mortality
death with any cause
Mortality
death with any cause
Quality of life(EORTC QLQ-C30)
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)
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)
Quality of life measured by EORTC QLQ-C30(Version 3)
Quality of life(EORTC QLC STO22)
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)
Quality of life measured by EORTC QLQ-C30(Version 3)
Quality of life(EORTC QLC STO22)
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).

Full Information

First Posted
December 20, 2017
Last Updated
March 17, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03385018
Brief Title
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Official Title
Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
772 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic group
Arm Type
Experimental
Arm Description
Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection
Arm Title
Open group
Arm Type
Active Comparator
Arm Description
Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
Intervention Description
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
Primary Outcome Measure Information:
Title
3 year relapse-free survival
Description
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".
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
3 year overall survival rate
Time Frame
3 years after surgery
Title
5 year relapse-free and overall survival
Time Frame
5 years after surgery
Title
Morbidity (early period)
Time Frame
from Operation day until POD 21
Title
Morbidity (late period)
Time Frame
from POD (Post-Operative Day) 22 until 5 years after surgery
Title
Mortality
Description
death with any cause
Time Frame
at POD 30
Title
Mortality
Description
death with any cause
Time Frame
at POD 90
Title
Quality of life(EORTC QLQ-C30)
Description
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).
Time Frame
at POD 21
Title
Quality of life(EORTC QLC STO22)
Description
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).
Time Frame
at POD 21
Title
Quality of life(EORTC QLQ-C30)
Description
Quality of life measured by EORTC QLQ-C30(Version 3)
Time Frame
3 months after surgery
Title
Quality of life(EORTC QLC STO22)
Description
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).
Time Frame
3 months after surgery
Title
Quality of life(EORTC QLQ-C30)
Description
Quality of life measured by EORTC QLQ-C30(Version 3)
Time Frame
12 months after surgery
Title
Quality of life(EORTC QLC STO22)
Description
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).
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woo Jin Hyung, MD, PhD
Phone
+82-2-2228-2100
Email
wjhyung@yuhs.ac
Facility Information:
Facility Name
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Jin Hyung, MD
Phone
+82-2-2228-2100
Email
WJHYUNG@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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