NCT01088204

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

March 15, 2010

Last Update Submit

October 5, 2015

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    postoperative 1 week

Secondary Outcomes (9)

  • Postoperative surgical complications

    postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months

  • operating time

    operation day

  • time to first flatus

    postoperative 1 week

  • number of retrieved lymph nodes

    postoperative 1 week

  • number of retrieved lymph nodes at each stations

    postoperative 1 week

  • +4 more secondary outcomes

Study Arms (2)

open distal gastrectomy

ACTIVE COMPARATOR

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

Procedure: open distal gastrectomy

laparoscopy assisted distal gastrectomy

EXPERIMENTAL

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

Procedure: laparoscopy assisted distal gastrectomy

Interventions

laparoscopy assisted distal gastrectomyPROCEDURE

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

Also known as: LADG
laparoscopy assisted distal gastrectomy
open distal gastrectomyPROCEDURE

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

Also known as: ODG
open distal gastrectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chonnam National University Hwasun Hospital

Hwasun, Chollanam Do, 519-763, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 411-764, South Korea

Location

Gyengsang National University Hospital

Jinju, Gyeongsangnam-do, 660-702, South Korea

Location

Kyungpook national university hospital

Daegu, 700-721, South Korea

Location

Dae Gu Veterans Hospital

Daegu, 704-802, South Korea

Location

Konyang University Hospital

Daejeon, 302-718, South Korea

Location

Kosin University Gospel Hospital

Pusan, 602-702, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 28187041DERIVED

  • 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.

    PMID: 24156036DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Young-Woo Kim, MD,PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Gastric Cancer Surgery

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 17, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2016

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

KR(7)