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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00112099
First Posted: May 30, 2005
Last Update Posted: September 22, 2016
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.
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
May 27, 2005
May 30, 2005
September 22, 2016
June 2002
March 2014   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: During the study conduct ]
Overall survival
Complete list of historical versions of study NCT00112099 on ClinicalTrials.gov Archive Site
  • Post-operative morbidity [ Time Frame: 5 years ]
  • operation time [ Time Frame: day of the operation ]
  • perioperative blood loss [ Time Frame: 3 days after operation ]
  • Post-operative morbidity
  • operation time
  • perioperative blood loss
Not Provided
Not Provided
 
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
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.

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

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Neoplasm
  • Procedure: Surgery: Splenectomy
    Procedure/Surgery: Surgery: Splenectomy
  • Procedure: Surgery: Spleen-preservation
    Procedure/Surgery: Surgery: Spleen-preservation
  • Active Comparator: 1
    Procedure/Surgery: Surgery: Splenectomy
    Intervention: Procedure: Surgery: Splenectomy
  • Experimental: 2
    Procedure/Surgery: Surgery: Spleen-preservation
    Intervention: Procedure: Surgery: Spleen-preservation
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.
 
Completed
500
March 2014
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00112099
JCOG 0110
C000000004
Yes
Not Provided
Not Provided
Haruhiko Fukuda, Japan Clinical Oncology Group
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
Japan Clinical Oncology Group
September 2016

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