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

Gastric Neoplasm Clinical Trial

Official title:

Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112099
• Other study ID #: JCOG 0110
• Secondary ID: C000000004
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2005
• Last updated: September 20, 2016
• Start date: June 2002
• Est. completion date: March 2014

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
• Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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

Outcome

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

External Links

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