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

October 5, 2015 updated by: Young-Woo Kim, National Cancer Center, Korea

A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Dae Gu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Dae Jeon, Korea, Republic of, 302-718
        • Konyang University Hospital
      • Daegu, Korea, Republic of, 704-802
        • Dae Gu Veterans Hospital
      • Pusan, Korea, Republic of, 602-702
        • Kosin university gospel hospital
    • Chollanam Do
      • Hwasun, Chollanam Do, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 411-764
        • National Cancer Center
    • Gyeongsangnam -Do
      • Jinju, Gyeongsangnam -Do, Korea, Republic of, 660-702
        • Gyengsang National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open distal gastrectomy
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Procedure: open distal gastrectomy
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Other Names:
  • ODG
Experimental: laparoscopy assisted distal gastrectomy
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Procedure: laparoscopy assisted distal gastrectomy
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Other Names:
  • LADG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
noncompliance rate
Time Frame: postoperative 1 week
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
postoperative 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative surgical complications
Time Frame: postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months
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.
postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months
operating time
Time Frame: operation day
From skin incision to wound closure
operation day
time to first flatus
Time Frame: postoperative 1 week
the day when a patient relieve gastrointestinal gas
postoperative 1 week
number of retrieved lymph nodes
Time Frame: postoperative 1 week
postoperative 1 week
number of retrieved lymph nodes at each stations
Time Frame: postoperative 1 week
postoperative 1 week
proximal resection margin
Time Frame: postoperative 1 week
postoperative 1 week
distal resection margin,
Time Frame: postoperative 1 week
postoperative 1 week
unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons
Time Frame: postoperative 3 months
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.
postoperative 3 months
3-year disease free survival
Time Frame: postoperative 3 years
postoperative 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Young-Woo Kim, MD,PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-09-448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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