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Status unknownNCT01088204COACT_1001Updated Oct 7, 2015

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

A Phase 2 interventional study of laparoscopy assisted distal gastrectomy and open distal gastrectomy in Gastric Cancer, sponsored by National Cancer Center, Korea. Status unknown at 7 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-07.

Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 204 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (actual)

Study arms

  • Active comparator
    open distal gastrectomy

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

    Procedure: open distal gastrectomy

  • 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

Interventions

  • Procedurelaparoscopy assisted distal gastrectomy

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

    Also known as: LADG

  • Procedureopen distal gastrectomy

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

    Also known as: ODG

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What researchers measure

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

    Time frame: postoperative 1 week

Secondary outcomes

  1. 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.

    Time frame: postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months

  2. operating time

    From skin incision to wound closure

    Time frame: operation day

  3. time to first flatus

    the day when a patient relieve gastrointestinal gas

    Time frame: postoperative 1 week

  4. number of retrieved lymph nodes

    Time frame: postoperative 1 week

  5. number of retrieved lymph nodes at each stations

    Time frame: postoperative 1 week

  6. proximal resection margin

    Time frame: postoperative 1 week

  7. distal resection margin,

    Time frame: postoperative 1 week

  8. 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.

    Time frame: postoperative 3 months

  9. 3-year disease free survival

    Time frame: postoperative 3 years

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Study locations

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

Publications

  • 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. PubMed 28187041 ↗
  • 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. PubMed 24156036 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01088204
Lead sponsor
National Cancer Center, Korea
Responsible party
Young-Woo Kim (Head of Department of Gastric Cancer Surgery, National Cancer Center, Korea) — Principal investigator
First posted
Mar 17, 2010
Start date
Jun 2010
Primary completion
Dec 2011
Completion
Dec 2016 (estimated)
Last update
Oct 7, 2015

Study contacts

Young-Woo Kim, MD,PhD
principal investigator · National Cancer Center, Korea

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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