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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Young-Woo Kim, National Cancer Center, Korea.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088204
First Posted: March 17, 2010
Last Update Posted: October 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Young-Woo Kim, National Cancer Center, Korea
March 15, 2010
March 17, 2010
October 7, 2015
June 2010
December 2011   (Final data collection date for primary outcome measure)
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
noncompliance rate [ Time Frame: postoperative 1 week ]
Cases where there was more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping
Complete list of historical versions of study NCT01088204 on ClinicalTrials.gov Archive Site
  • 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.
  • operating time [ Time Frame: operation day ]
    From skin incision to wound closure
  • time to first flatus [ Time Frame: postoperative 1 week ]
    the day when a patient relieve gastrointestinal gas
  • number of retrieved lymph nodes [ Time Frame: postoperative 1 week ]
  • number of retrieved lymph nodes at each stations [ Time Frame: postoperative 1 week ]
  • proximal resection margin [ Time Frame: postoperative 1 week ]
  • distal resection margin, [ Time Frame: 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.
  • 3-year disease free survival [ Time Frame: postoperative 3 years ]
Postopertive surgical complications [ Time Frame: postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months ]
Major and minor, and shorterm and long term complicatins related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification.
Not Provided
Not Provided
 
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Procedure: laparoscopy assisted distal gastrectomy
    laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
    Other Name: LADG
  • Procedure: open distal gastrectomy
    open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
    Other Name: ODG
  • Active Comparator: open distal gastrectomy
    open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
    Intervention: Procedure: open distal gastrectomy
  • Experimental: laparoscopy assisted distal gastrectomy
    laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
    Intervention: Procedure: laparoscopy assisted distal gastrectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
204
December 2016
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01088204
NCCCTS-09-448
Yes
Not Provided
Not Provided
Young-Woo Kim, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Young-Woo Kim, MD,PhD National Cancer Center, Korea
National Cancer Center, Korea
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP