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

Primary Purpose

Gastric Neoplasm

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Surgery: Splenectomy
Surgery: Spleen-preservation
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Neoplasm focused on measuring gastric neoplasm, gastrectomy, splenectomy, randomized trial, T2, T3 and T4 carcinoma in the proximal third of the stomach

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aichi Cancer Center Hospital
  • Fujita Health University
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Gifu Municipal Hospital
  • Hiroshima City Hospital
  • Itami City Hospital
  • Iwate Medical University
  • Kagoshima University,Faculty of Medicine
  • Kanagawa Cancer Center
  • Kyoto Second Red Cross Hospital
  • Miyagi Cancer Center
  • National Hospital Organization, Sendai Medical Center
  • Nagaoka Chuo General Hospital
  • Niigata Cancer Center Hospital
  • Tsubame Rosai Hospital
  • Oita University Fuculty of Medicine
  • Osaka National Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kinki University School of Medicine
  • Sakai Municipal Hospital
  • Osaka Medical College
  • Toyonaka Municipal Hospital
  • Saitama Cancer Center
  • National Defense Medical College
  • Shizuoka General Hospital
  • Tokyo Metropolitan Komagome Hospital
  • Tokyo Medical and Dental University Hospital
  • National Cancer Center Hospital
  • Cancer Institute Hospital
  • International Medical Center of Japan
  • Tokyo Metropolitan Bokutoh Hospital
  • Toyama Prefectural Central Hospital
  • Wakayama Medical University, School of Medicine
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Procedure/Surgery: Surgery: Splenectomy

Procedure/Surgery: Surgery: Spleen-preservation

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Post-operative morbidity
operation time
perioperative blood loss

Full Information

First Posted
May 27, 2005
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00112099
Brief Title
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Official Title
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasm
Keywords
gastric neoplasm, gastrectomy, splenectomy, randomized trial, T2, T3 and T4 carcinoma in the proximal third of the stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Surgery: Splenectomy
Arm Title
2
Arm Type
Experimental
Arm Description
Procedure/Surgery: Surgery: Spleen-preservation
Intervention Type
Procedure
Intervention Name(s)
Surgery: Splenectomy
Intervention Description
Procedure/Surgery: Surgery: Splenectomy
Intervention Type
Procedure
Intervention Name(s)
Surgery: Spleen-preservation
Intervention Description
Procedure/Surgery: Surgery: Spleen-preservation
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
During the study conduct
Secondary Outcome Measure Information:
Title
Post-operative morbidity
Time Frame
5 years
Title
operation time
Time Frame
day of the operation
Title
perioperative blood loss
Time Frame
3 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsuru Sasako, MD, PhD
Organizational Affiliation
Hyogo Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Fujita Health University
City
Toyoake,Kutsukake-cho,Dengakugakubo,1-98
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu,Kashima-cho,7-1
State/Province
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Hiroshima City Hospital
City
Hiroshima,Naka-ku,Motomachi,7-33
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Itami City Hospital
City
Itami,Koyaike,1-100
State/Province
Hyogo
ZIP/Postal Code
664-8540
Country
Japan
Facility Name
Iwate Medical University
City
Morioka,Uchimaru,19-1
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Kagoshima University,Faculty of Medicine
City
Kagoshima,Sakuragaoka,8-35-1
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Kyoto Second Red Cross Hospital
City
Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5
State/Province
Kyoto
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Miyagi Cancer Center
City
Natori,Medeshima-Shiode,Nodayama,47-1
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
National Hospital Organization, Sendai Medical Center
City
Sendai,Miyagino-ku,Miyagino,2-8-8
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Nagaoka Chuo General Hospital
City
Nagaoka,Kawasaki,2041
State/Province
Niigata
ZIP/Postal Code
940-8653
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Tsubame Rosai Hospital
City
Tsubame,Sawatari,633
State/Province
Niigata
ZIP/Postal Code
959-1228
Country
Japan
Facility Name
Oita University Fuculty of Medicine
City
Oita1-1,Hasama-machi,Oogaoka
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Osaka National Hospital
City
Osaka,Chuo-ku,Hoenzaka,2-1-14
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama,Ohno-higashi,377-2
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Sakai Municipal Hospital
City
Sakai,Minamiyasuicho,1-1-1
State/Province
Osaka
ZIP/Postal Code
590-0064
Country
Japan
Facility Name
Osaka Medical College
City
Takatsuki,Daigakucho,2-7
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Toyonaka Municipal Hospital
City
Toyonaka,Shibaharacho,4-14-1
State/Province
Osaka
ZIP/Postal Code
560-0055
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Defense Medical College
City
Tokorozawa,Namiki,3-2
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Shizuoka General Hospital
City
Shizuoka,Aoi-ku,Kitaando,4-27-1
State/Province
Sizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-ku,Honkomagome,3-18-22
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku,Yushima,1-5-45
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku,Ariake,3-10-6
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku,Toyama,1-21-1
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Tokyo Metropolitan Bokutoh Hospital
City
Sumida-ku,Koutoubashi,4-23-15
State/Province
Tokyo
ZIP/Postal Code
130-8575
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama,Nishinagae,2-2-78
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Wakayama Medical University, School of Medicine
City
Wakayama,Kimiidera,811-1
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
12417603
Citation
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. doi: 10.1093/jjco/hyf085.
Results Reference
background
Links:
URL
http://www.jcog.jp/
Description
Related Info
URL
http://jjco.oxfordjournals.org/cgi/content/full/32/9/363?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=splenectomy&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
Description
Related Info

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

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