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Gastric CancerPhase 2COACT_1001NCT01088204

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

A Phase 2 study testing laparoscopy assisted distal gastrectomy and open distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 7 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
laparoscopy assisted distal gastrectomy and open distal gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
7 sitesSouth Korea
Study dates
Jun 2010to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Kyungpook national university hospital

    Daegu, 700-721

  • Dae Gu Veterans Hospital

    Daegu, 704-802

  • Konyang University Hospital

    Daejeon, 302-718

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 411-764

  • Chonnam National University Hwasun Hospital

    Hwasun, Chollanam Do, 519-763

  • Gyengsang National University Hospital

    Jinju, Gyeongsangnam-do, 660-702

  • Kosin University Gospel Hospital

    Pusan, 602-702

Other trials in South Korea

About this study

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

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.

Conditions
Gastric Cancer
Being tested
laparoscopy assisted distal gastrectomy, open distal gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laparoscopy assisted distal gastrectomyProcedure or surgery

    Also called LADG

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

  • open distal gastrectomyProcedure or surgery

    Also called ODG

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

Study groups in NCT01088204
Study groupRoleWhat they receive
open distal gastrectomyActive comparatoropen distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Receives: Procedure: open distal gastrectomy
laparoscopy assisted distal gastrectomyExperimentallaparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Receives: Procedure: laparoscopy assisted distal gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: postoperative 1 week

Secondary outcomes (9)

  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.

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

  2. operating time

    From skin incision to wound closure

    Measured: operation day

  3. time to first flatus

    the day when a patient relieve gastrointestinal gas

    Measured: postoperative 1 week

  4. number of retrieved lymph nodes

    Measured: postoperative 1 week

  5. number of retrieved lymph nodes at each stations

    Measured: postoperative 1 week

  6. proximal resection margin

    Measured: postoperative 1 week

  7. distal resection margin,

    Measured: 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.

    Measured: postoperative 3 months

  9. 3-year disease free survival

    Measured: postoperative 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2011
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01088204
Sponsor's protocol ID
NCCCTS-09-448
Acronym
COACT_1001
Status last verified
Oct 2015
First submitted
15 Mar 2010
Last updated
7 Oct 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing laparoscopy assisted distal gastrectomy and open distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

noncompliance rate (time frame: postoperative 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01088204, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.

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