GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
NCT ID: NCT00112099
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2002-06-30
2014-03-31
Brief Summary
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Detailed Description
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Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Procedure/Surgery: Surgery: Splenectomy
Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
2
Procedure/Surgery: Surgery: Spleen-preservation
Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation
Interventions
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Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation
Eligibility Criteria
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Inclusion Criteria
* 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
* Idiopathic thrombocytopenic purpura
* Severe pulmonary dysfunction
* Synchronous or metachronous (within 5 years) malignancy.
20 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
Principal Investigators
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Mitsuru Sasako, MD, PhD
Role: STUDY_CHAIR
Hyogo Medical University
Locations
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Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, Japan
Hiroshima City Hospital
Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan
Itami City Hospital
Itami,Koyaike,1-100, Hyōgo, Japan
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan
Kyoto Second Red Cross Hospital
Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan
National Hospital Organization, Sendai Medical Center
Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan
Nagaoka Chuo General Hospital
Nagaoka,Kawasaki,2041, Niigata, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan
Tsubame Rosai Hospital
Tsubame,Sawatari,633, Niigata, Japan
Oita University Fuculty of Medicine
Oita1-1,Hasama-machi,Oogaoka, Oita Prefecture, Japan
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan
Sakai Municipal Hospital
Sakai,Minamiyasuicho,1-1-1, Osaka, Japan
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, Japan
Toyonaka Municipal Hospital
Toyonaka,Shibaharacho,4-14-1, Osaka, Japan
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, Japan
Shizuoka General Hospital
Shizuoka,Aoi-ku,Kitaando,4-27-1, Shizuoka, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan
Toyama Prefectural Central Hospital
Toyama,Nishinagae,2-2-78, Toyama, Japan
Wakayama Medical University, School of Medicine
Wakayama,Kimiidera,811-1, Wakayama, Japan
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, Japan
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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C000000004
Identifier Type: -
Identifier Source: secondary_id
JCOG 0110
Identifier Type: -
Identifier Source: org_study_id
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