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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Neoplasm Procedure: Surgery: Splenectomy Procedure: Surgery: Spleen-preservation Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Study Start Date : June 2002
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Procedure/Surgery: Surgery: Splenectomy
 Procedure: Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
Experimental: 2
Procedure/Surgery: Surgery: Spleen-preservation
 Procedure: Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. Post-operative morbidity [ Time Frame: 5 years ]
  2. operation time [ Time Frame: day of the operation ]
  3. perioperative blood loss [ Time Frame: 3 days after operation ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112099


Locations
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Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site Related Info  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00112099    
Other Study ID Numbers: JCOG 0110
C000000004
First Posted: May 30, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
gastric neoplasm
gastrectomy
splenectomy
randomized trial
T2, T3 and T4 carcinoma in the proximal third of the stomach
Additional relevant MeSH terms:
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Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases