- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112099
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Aichi
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Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan, 470-1192
- Fujita Health University
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Chiba
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Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime
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Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
- National Hospital Organization Shikoku Cancer Center
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Gifu
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Gifu,Kashima-cho,7-1, Gifu, Japan, 500-8323
- Gifu Municipal Hospital
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Hiroshima
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Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan, 730-8518
- Hiroshima City Hospital
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Hyogo
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Itami,Koyaike,1-100, Hyogo, Japan, 664-8540
- Itami City Hospital
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Iwate
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Morioka,Uchimaru,19-1, Iwate, Japan, 020-8505
- Iwate Medical University
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Kagoshima
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Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan, 890-8520
- Kagoshima University,Faculty of Medicine
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Kanagawa
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Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
- Kanagawa Cancer Center
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Kyoto
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Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan, 602-8026
- Kyoto Second Red Cross Hospital
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Miyagi
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Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan, 981-1293
- Miyagi Cancer Center
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Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan, 983-8520
- National Hospital Organization, Sendai Medical Center
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Niigata
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Nagaoka,Kawasaki,2041, Niigata, Japan, 940-8653
- Nagaoka Chuo General Hospital
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Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Tsubame,Sawatari,633, Niigata, Japan, 959-1228
- Tsubame Rosai Hospital
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Oita
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Oita1-1,Hasama-machi,Oogaoka, Oita, Japan, 879-5593
- Oita University Fuculty of Medicine
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Osaka
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Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
- Osaka National Hospital
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Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
- Osaka Medical Center for Cancer and Cardiovascular Diseases
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Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
- Kinki University School of Medicine
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Sakai,Minamiyasuicho,1-1-1, Osaka, Japan, 590-0064
- Sakai Municipal Hospital
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Takatsuki,Daigakucho,2-7, Osaka, Japan, 569-0801
- Osaka Medical College
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Toyonaka,Shibaharacho,4-14-1, Osaka, Japan, 560-0055
- Toyonaka Municipal Hospital
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Saitama
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Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
- Saitama Cancer Center
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Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
- National Defense Medical College
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Sizuoka
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Shizuoka,Aoi-ku,Kitaando,4-27-1, Sizuoka, Japan, 420-8527
- Shizuoka General Hospital
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Tokyo
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Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan, 113-8677
- Tokyo Metropolitan Komagome Hospital
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Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University Hospital
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Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
- Cancer Institute Hospital
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Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan, 162-8655
- International Medical Center of Japan
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Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan, 130-8575
- Tokyo Metropolitan Bokutoh Hospital
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Toyama
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Toyama,Nishinagae,2-2-78, Toyama, Japan, 930-8550
- Toyama Prefectural Central Hospital
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Wakayama
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Wakayama,Kimiidera,811-1, Wakayama, Japan, 641-8510
- Wakayama Medical University, School of Medicine
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Yamagata
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Yamagata,Aoyagi,1800, Yamagata, Japan, 990-2292
- Yamagata Prefectural Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Procedure/Surgery: Surgery: Splenectomy
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Procedure/Surgery: Surgery: Splenectomy
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Experimental: 2
Procedure/Surgery: Surgery: Spleen-preservation
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Procedure/Surgery: Surgery: Spleen-preservation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: During the study conduct
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During the study conduct
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Post-operative morbidity
Time Frame: 5 years
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5 years
|
operation time
Time Frame: day of the operation
|
day of the operation
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perioperative blood loss
Time Frame: 3 days after operation
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3 days after operation
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Mitsuru Sasako, MD, PhD, Hyogo College of Medicine
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JCOG 0110
- C000000004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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