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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Young-Woo Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01088204
First received: March 15, 2010
Last updated: February 25, 2014
Last verified: February 2014

March 15, 2010
February 25, 2014
June 2010
December 2011   (final data collection date for primary outcome measure)
noncompliance rate [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    From skin incision to wound closure
  • time to first flatus [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
    the day when a patient relieve gastrointestinal gas
  • number of retrieved lymph nodes [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
  • number of retrieved lymph nodes at each stations [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
  • proximal resection margin [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
  • distal resection margin, [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
  • unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons [ Time Frame: postoperative 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Postopertive surgical complications [ Time Frame: postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01088204
NCCCTS-09-448
Yes
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
February 2014

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