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GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

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.
 
ClinicalTrials.gov Identifier: NCT00112099
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

Tracking Information
First Submitted Date  ICMJE May 27, 2005
First Posted Date  ICMJE May 30, 2005
Last Update Posted Date September 22, 2016
Study Start Date  ICMJE June 2002
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
Overall survival [ Time Frame: During the study conduct ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
  • Post-operative morbidity [ Time Frame: 5 years ]
  • operation time [ Time Frame: day of the operation ]
  • perioperative blood loss [ Time Frame: 3 days after operation ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Post-operative morbidity
  • operation time
  • perioperative blood loss
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Official Title  ICMJE Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Brief Summary The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.
Detailed Description

European clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. Retrospective comparisons suggested that splenectomy is associated with poor long term survival. However, Japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. There have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer.

Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Neoplasm
Intervention  ICMJE
  • Procedure: Surgery: Splenectomy
    Procedure/Surgery: Surgery: Splenectomy
  • Procedure: Surgery: Spleen-preservation
    Procedure/Surgery: Surgery: Spleen-preservation
Study Arms  ICMJE
  • Active Comparator: 1
    Procedure/Surgery: Surgery: Splenectomy
    Intervention: Procedure: Surgery: Splenectomy
  • Experimental: 2
    Procedure/Surgery: Surgery: Spleen-preservation
    Intervention: Procedure: Surgery: Spleen-preservation
Publications * Sano T, Yamamoto S, Sasako M; Japan Clinical Oncology Group Study LCOG 0110-MF. Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma: Japan clinical oncology group study JCOG 0110-MF. Jpn J Clin Oncol. 2002 Sep;32(9):363-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Preoperatively

  • Histologically proven adenocarcinoma
  • T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion, irrespective of the primary tumor location or existence of multiple foci
  • No distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer
  • Sufficient organ function
  • Written informed consent.

Intra-operatively

  • T2/T3/T4 and N0/N1/N2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology
  • No apparent nodal metastasis in the splenic hilum or along the splenic artery

Exclusion Criteria:

  • Liver cirrhosis or portal hypertension
  • Idiopathic thrombocytopenic purpura
  • Severe pulmonary dysfunction
  • Synchronous or metachronous (within 5 years) malignancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00112099
Other Study ID Numbers  ICMJE JCOG 0110
C000000004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haruhiko Fukuda, Japan Clinical Oncology Group
Study Sponsor  ICMJE Haruhiko Fukuda
Collaborators  ICMJE Ministry of Health, Labour and Welfare, Japan
Investigators  ICMJE
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
PRS Account Japan Clinical Oncology Group
Verification Date September 2016

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