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
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Procedure: laparoscopy assisted distal gastrectomy
Procedure: open distal gastrectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 204
Study Start Date: June 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open distal gastrectomy
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Procedure: open distal gastrectomy
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Other Name: ODG
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
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Other Name: LADG

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088204

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Chollanam Do, Korea, Republic of, 519-763
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 411-764
Gyengsang National University Hospital
Jinju, Gyeongsangnam -Do, Korea, Republic of, 660-702
Kyungpook national university hospital
Dae Gu, Korea, Republic of, 700-721
Konyang University Hospital
Dae Jeon, Korea, Republic of, 302-718
Dae Gu Veterans Hospital
Daegu, Korea, Republic of, 704-802
Kosin University Gospel Hospital
Pusan, Korea, Republic of, 602-702
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Young-Woo Kim, MD,PhD National Cancer Center, Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Young-Woo Kim, Head of Department of Gastric Cancer Surgery, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01088204     History of Changes
Other Study ID Numbers: NCCCTS-09-448
Study First Received: March 15, 2010
Last Updated: February 25, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 25, 2014