Gastric Neoplasm Clinical Trial
Official title:
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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 | 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 | Hyogo |
Japan | Kagoshima University,Faculty of Medicine | Kagoshima,Sakuragaoka,8-35-1 | Kagoshima |
Japan | National Cancer Center Hospital East | Kashiwa,Kashiwanoha,6-5-1 | Chiba |
Japan | Saitama Cancer Center | Kita-adachi,Ina,Komuro,818 | Saitama |
Japan | Cancer Institute Hospital | Koto-ku,Ariake,3-10-6 | Tokyo |
Japan | Kyoto Second Red Cross Hospital | Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5 | Kyoto |
Japan | National Hospital Organization Shikoku Cancer Center | Matsuyama,Horinouchi,13 | Ehime |
Japan | Iwate Medical University | Morioka,Uchimaru,19-1 | Iwate |
Japan | Nagaoka Chuo General Hospital | Nagaoka,Kawasaki,2041 | Niigata |
Japan | Aichi Cancer Center Hospital | Nagoya,Chikusa-ku,Kanokoden,1-1 | Aichi |
Japan | Miyagi Cancer Center | Natori,Medeshima-Shiode,Nodayama,47-1 | Miyagi |
Japan | Niigata Cancer Center Hospital | Niigata,Kawagishi-cho,2-15-3 | Niigata |
Japan | Oita University Fuculty of Medicine | Oita1-1,Hasama-machi,Oogaoka | Oita |
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 | National Hospital Organization, Sendai Medical Center | Sendai,Miyagino-ku,Miyagino,2-8-8 | Miyagi |
Japan | International Medical Center of Japan | Shinjuku-ku,Toyama,1-21-1 | Tokyo |
Japan | Shizuoka General Hospital | Shizuoka,Aoi-ku,Kitaando,4-27-1 | Sizuoka |
Japan | Tokyo Metropolitan Bokutoh Hospital | Sumida-ku,Koutoubashi,4-23-15 | Tokyo |
Japan | Osaka Medical College | Takatsuki,Daigakucho,2-7 | Osaka |
Japan | National Defense Medical College | Tokorozawa,Namiki,3-2 | Saitama |
Japan | Toyama Prefectural Central Hospital | Toyama,Nishinagae,2-2-78 | Toyama |
Japan | Fujita Health University | Toyoake,Kutsukake-cho,Dengakugakubo,1-98 | Aichi |
Japan | Toyonaka Municipal Hospital | Toyonaka,Shibaharacho,4-14-1 | Osaka |
Japan | Tsubame Rosai Hospital | Tsubame,Sawatari,633 | Niigata |
Japan | Wakayama Medical University, School of Medicine | Wakayama,Kimiidera,811-1 | Wakayama |
Japan | Yamagata Prefectural Central Hospital | Yamagata,Aoyagi,1800 | Yamagata |
Japan | Kanagawa Cancer Center | Yokohama,Asahi-ku,Nakao,1-1-2 | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
Haruhiko Fukuda | Ministry of Health, Labour and Welfare, Japan |
Japan,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | During the study conduct | No | |
Secondary | Post-operative morbidity | 5 years | Yes | |
Secondary | operation time | day of the operation | Yes | |
Secondary | perioperative blood loss | 3 days after operation | Yes |
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