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Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer (COACT_1001)

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
laparoscopy assisted distal gastrectomy
open distal gastrectomy
Sponsored by
National Cancer Center, Korea
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:

  • histologically proven primary gastric adenocarcinoma
  • T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
  • No evidence of other distant metastasis
  • not stump carcinoma,(vi) aged 20-80 year old
  • performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection

  • adequate organ functions defined as indicated below:

    • WBC 3000/mm3, WBC 12 000/mm3
    • Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
    • Plt 100 000/mm3
    • AST 100 IU/l
    • ALT 100 IU/l
    • T.Bil 2.0 mg/dl
    • written informed consent

Exclusion Criteria:

  • active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
  • pregnant or breast-feeding women
  • severe mental disorder
  • systemic administration of corticosteroids
  • unstable angina or myocardial infarction within 6 months of the trial
  • unstable hypertension
  • severe respiratory disease requiring continuous oxygen therapy
  • previous upper abdominal surgery except laparoscopic cholecystectomy

Sites / Locations

  • Chonnam National University Hwasun Hospital
  • National Cancer Center
  • Gyengsang National University Hospital
  • Kyungpook national university hospital
  • Konyang University Hospital
  • Dae Gu Veterans Hospital
  • Kosin University Gospel Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

open distal gastrectomy

laparoscopy assisted distal gastrectomy

Arm Description

open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Outcomes

Primary Outcome Measures

noncompliance rate
A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping

Secondary Outcome Measures

Postoperative surgical complications
Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification.
operating time
From skin incision to wound closure
time to first flatus
the day when a patient relieve gastrointestinal gas
number of retrieved lymph nodes
number of retrieved lymph nodes at each stations
proximal resection margin
distal resection margin,
unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons
Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity.
3-year disease free survival

Full Information

First Posted
March 15, 2010
Last Updated
October 5, 2015
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01088204
Brief Title
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer
Acronym
COACT_1001
Official Title
A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
Detailed Description
To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

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
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open distal gastrectomy
Arm Type
Active Comparator
Arm Description
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Arm Title
laparoscopy assisted distal gastrectomy
Arm Type
Experimental
Arm Description
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Intervention Type
Procedure
Intervention Name(s)
laparoscopy assisted distal gastrectomy
Other Intervention Name(s)
LADG
Intervention Description
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Intervention Type
Procedure
Intervention Name(s)
open distal gastrectomy
Other Intervention Name(s)
ODG
Intervention Description
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Primary Outcome Measure Information:
Title
noncompliance rate
Description
A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping
Time Frame
postoperative 1 week
Secondary Outcome Measure Information:
Title
Postoperative surgical complications
Description
Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification.
Time Frame
postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months
Title
operating time
Description
From skin incision to wound closure
Time Frame
operation day
Title
time to first flatus
Description
the day when a patient relieve gastrointestinal gas
Time Frame
postoperative 1 week
Title
number of retrieved lymph nodes
Time Frame
postoperative 1 week
Title
number of retrieved lymph nodes at each stations
Time Frame
postoperative 1 week
Title
proximal resection margin
Time Frame
postoperative 1 week
Title
distal resection margin,
Time Frame
postoperative 1 week
Title
unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons
Description
Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity.
Time Frame
postoperative 3 months
Title
3-year disease free survival
Time Frame
postoperative 3 years

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: histologically proven primary gastric adenocarcinoma T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location No evidence of other distant metastasis not stump carcinoma,(vi) aged 20-80 year old performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection adequate organ functions defined as indicated below: WBC 3000/mm3, WBC 12 000/mm3 Hb 8.0 g/dl without any transfusion 2 weeks before enrollment Plt 100 000/mm3 AST 100 IU/l ALT 100 IU/l T.Bil 2.0 mg/dl written informed consent Exclusion Criteria: active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) pregnant or breast-feeding women severe mental disorder systemic administration of corticosteroids unstable angina or myocardial infarction within 6 months of the trial unstable hypertension severe respiratory disease requiring continuous oxygen therapy previous upper abdominal surgery except laparoscopic cholecystectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Woo Kim, MD,PhD
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Chollanam Do
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
411-764
Country
Korea, Republic of
Facility Name
Gyengsang National University Hospital
City
Jinju
State/Province
Gyeongsangnam -Do
ZIP/Postal Code
660-702
Country
Korea, Republic of
Facility Name
Kyungpook national university hospital
City
Dae Gu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Dae Jeon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Facility Name
Dae Gu Veterans Hospital
City
Daegu
ZIP/Postal Code
704-802
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Pusan
ZIP/Postal Code
602-702
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28187041
Citation
Park YK, Yoon HM, Kim YW, Park JY, Ryu KW, Lee YJ, Jeong O, Yoon KY, Lee JH, Lee SE, Yu W, Jeong SH, Kim T, Kim S, Nam BH; COACT group. Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001). Ann Surg. 2018 Apr;267(4):638-645. doi: 10.1097/SLA.0000000000002168.
Results Reference
derived
PubMed Identifier
24156036
Citation
Nam BH, Kim YW, Reim D, Eom BW, Yu WS, Park YK, Ryu KW, Lee YJ, Yoon HM, Lee JH, Jeong O, Jeong SH, Lee SE, Lee SH, Yoon KY, Seo KW, Chung HY, Kwon OK, Kim TB, Lee WK, Park SH, Sul JY, Yang DH, Lee JS. Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001). J Gastric Cancer. 2013 Sep;13(3):164-71. doi: 10.5230/jgc.2013.13.3.164. Epub 2013 Sep 30.
Results Reference
derived
Links:
URL
http://ncc.re.kr
Description
National Cancer Center web site

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Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

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