Status:
COMPLETED
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Gastric Neoplasm
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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 associat...
Eligibility Criteria
Inclusion
- 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
- Liver cirrhosis or portal hypertension
- Idiopathic thrombocytopenic purpura
- Severe pulmonary dysfunction
- Synchronous or metachronous (within 5 years) malignancy.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00112099
Start Date
June 1 2002
End Date
March 1 2014
Last Update
September 22 2016
Active Locations (35)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan, 470-1192
3
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007