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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00112099
First received: May 27, 2005
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Gastric Neoplasm
Procedure: Surgery: Splenectomy
Procedure: Surgery: Spleen-preservation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative morbidity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • operation time [ Time Frame: day of the operation ] [ Designated as safety issue: Yes ]
  • perioperative blood loss [ Time Frame: 3 days after operation ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: June 2002
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112099

Locations
Japan
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan, 470-1192
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
Hiroshima City Hospital
Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan, 730-8518
Itami City Hospital
Itami,Koyaike,1-100, Hyogo, Japan, 664-8540
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan, 020-8505
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan, 890-8520
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
Kyoto Second Red Cross Hospital
Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan, 602-8026
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan, 981-1293
National Hospital Organization, Sendai Medical Center
Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan, 983-8520
Nagaoka Chuo General Hospital
Nagaoka,Kawasaki,2041, Niigata, Japan, 940-8653
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Tsubame Rosai Hospital
Tsubame,Sawatari,633, Niigata, Japan, 959-1228
Oita University Fuculty of Medicine
Oita1-1,Hasama-machi,Oogaoka, Oita, Japan, 879-5593
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
Sakai Municipal Hospital
Sakai,Minamiyasuicho,1-1-1, Osaka, Japan, 590-0064
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
Toyonaka Municipal Hospital
Toyonaka,Shibaharacho,4-14-1, Osaka, Japan, 560-0055
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
Shizuoka General Hospital
Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan, 420-8527
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan, 113-8677
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan, 130-8575
Toyama Prefectural Central Hospital
Toyama,Nishinagae,2-2-78, Toyama, Japan, 930-8550
Wakayama Medical University, School of Medicine
Wakayama,Kimiidera,811-1, Wakayama, Japan, 641-8510
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Mitsuru Sasako, MD, PhD Hyogo College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00112099     History of Changes
Other Study ID Numbers: JCOG 0110  C000000004 
Study First Received: May 27, 2005
Last Updated: September 20, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by 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:
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

ClinicalTrials.gov processed this record on September 30, 2016