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

NCT ID: NCT00112099

Last Updated: 2016-09-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Gastric Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Procedure/Surgery: Surgery: Splenectomy

Group Type ACTIVE_COMPARATOR

Surgery: Splenectomy

Intervention Type PROCEDURE

Procedure/Surgery: Surgery: Splenectomy

2

Procedure/Surgery: Surgery: Spleen-preservation

Group Type EXPERIMENTAL

Surgery: Spleen-preservation

Intervention Type PROCEDURE

Procedure/Surgery: Surgery: Spleen-preservation

Interventions

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Surgery: Splenectomy

Procedure/Surgery: Surgery: Splenectomy

Intervention Type PROCEDURE

Surgery: Spleen-preservation

Procedure/Surgery: Surgery: Spleen-preservation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Labour and Welfare, Japan

OTHER_GOV

Sponsor Role collaborator

Haruhiko Fukuda

OTHER

Sponsor Role lead

Responsible Party

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Haruhiko Fukuda

JCOG Data Center

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Site Status

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Site Status

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, Japan

Site Status

Hiroshima City Hospital

Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan

Site Status

Itami City Hospital

Itami,Koyaike,1-100, Hyōgo, Japan

Site Status

Iwate Medical University

Morioka,Uchimaru,19-1, Iwate, Japan

Site Status

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, Japan

Site Status

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

Site Status

Kyoto Second Red Cross Hospital

Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, Japan

Site Status

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, Japan

Site Status

National Hospital Organization, Sendai Medical Center

Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, Japan

Site Status

Nagaoka Chuo General Hospital

Nagaoka,Kawasaki,2041, Niigata, Japan

Site Status

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, Japan

Site Status

Tsubame Rosai Hospital

Tsubame,Sawatari,633, Niigata, Japan

Site Status

Oita University Fuculty of Medicine

Oita1-1,Hasama-machi,Oogaoka, Oita Prefecture, Japan

Site Status

Osaka National Hospital

Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan

Site Status

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan

Site Status

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan

Site Status

Sakai Municipal Hospital

Sakai,Minamiyasuicho,1-1-1, Osaka, Japan

Site Status

Osaka Medical College

Takatsuki,Daigakucho,2-7, Osaka, Japan

Site Status

Toyonaka Municipal Hospital

Toyonaka,Shibaharacho,4-14-1, Osaka, Japan

Site Status

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, Japan

Site Status

National Defense Medical College

Tokorozawa,Namiki,3-2, Saitama, Japan

Site Status

Shizuoka General Hospital

Shizuoka,Aoi-ku,Kitaando,4-27-1, Shizuoka, Japan

Site Status

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan

Site Status

Tokyo Medical and Dental University Hospital

Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan

Site Status

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan

Site Status

Cancer Institute Hospital

Koto-ku,Ariake,3-10-6, Tokyo, Japan

Site Status

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, Japan

Site Status

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku,Koutoubashi,4-23-15, Tokyo, Japan

Site Status

Toyama Prefectural Central Hospital

Toyama,Nishinagae,2-2-78, Toyama, Japan

Site Status

Wakayama Medical University, School of Medicine

Wakayama,Kimiidera,811-1, Wakayama, Japan

Site Status

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, Japan

Site Status

Countries

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Japan

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.

Reference Type BACKGROUND
PMID: 12417603 (View on PubMed)

Related Links

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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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