NCT00112099

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_3

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2005

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

11.8 years

First QC Date

May 27, 2005

Last Update Submit

September 20, 2016

Conditions

Gastric Neoplasm

Keywords

gastric neoplasmgastrectomysplenectomyrandomized trialT2, T3 and T4 carcinoma in the proximal third of the stomach

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    During the study conduct

Secondary Outcomes (3)

  • Post-operative morbidity

    5 years

  • operation time

    day of the operation

  • perioperative blood loss

    3 days after operation

Study Arms (2)

1

ACTIVE COMPARATOR

Procedure/Surgery: Surgery: Splenectomy

Procedure: Surgery: Splenectomy

2

EXPERIMENTAL

Procedure/Surgery: Surgery: Spleen-preservation

Procedure: Surgery: Spleen-preservation

Interventions

Surgery: SplenectomyPROCEDURE

Procedure/Surgery: Surgery: Splenectomy

1
Surgery: Spleen-preservationPROCEDURE

Procedure/Surgery: Surgery: Spleen-preservation

2

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Liver cirrhosis or portal hypertension
  • Idiopathic thrombocytopenic purpura
  • Severe pulmonary dysfunction
  • Synchronous or metachronous (within 5 years) malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan

Location

Fujita Health University

Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan

Location

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, 500-8323, Japan

Location

Hiroshima City Hospital

Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, 730-8518, Japan

Location

Itami City Hospital

Itami,Koyaike,1-100, Hyōgo, 664-8540, Japan

Location

Iwate Medical University

Morioka,Uchimaru,19-1, Iwate, 020-8505, Japan

Location

Kagoshima University,Faculty of Medicine

Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520, Japan

Location

Kanagawa Cancer Center

Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan

Location

Kyoto Second Red Cross Hospital

Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, 602-8026, Japan

Location

Miyagi Cancer Center

Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293, Japan

Location

National Hospital Organization, Sendai Medical Center

Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, 983-8520, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka,Kawasaki,2041, Niigata, 940-8653, Japan

Location

Niigata Cancer Center Hospital

Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan

Location

Tsubame Rosai Hospital

Tsubame,Sawatari,633, Niigata, 959-1228, Japan

Location

Oita University Fuculty of Medicine

Oita1-1,Hasama-machi,Oogaoka, Oita Prefecture, 879-5593, Japan

Location

Osaka National Hospital

Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006, Japan

Location

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan

Location

Kinki University School of Medicine

Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511, Japan

Location

Sakai Municipal Hospital

Sakai,Minamiyasuicho,1-1-1, Osaka, 590-0064, Japan

Location

Osaka Medical College

Takatsuki,Daigakucho,2-7, Osaka, 569-0801, Japan

Location

Toyonaka Municipal Hospital

Toyonaka,Shibaharacho,4-14-1, Osaka, 560-0055, Japan

Location

Saitama Cancer Center

Kita-adachi,Ina,Komuro,818, Saitama, 362-0806, Japan

Location

National Defense Medical College

Tokorozawa,Namiki,3-2, Saitama, 359-8513, Japan

Location

Shizuoka General Hospital

Shizuoka,Aoi-ku,Kitaando,4-27-1, Shizuoka, 420-8527, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677, Japan

Location

Tokyo Medical and Dental University Hospital

Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519, Japan

Location

National Cancer Center Hospital

Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital

Koto-ku,Ariake,3-10-6, Tokyo, 135-8550, Japan

Location

International Medical Center of Japan

Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655, Japan

Location

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku,Koutoubashi,4-23-15, Tokyo, 130-8575, Japan

Location

Toyama Prefectural Central Hospital

Toyama,Nishinagae,2-2-78, Toyama, 930-8550, Japan

Location

Wakayama Medical University, School of Medicine

Wakayama,Kimiidera,811-1, Wakayama, 641-8510, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata,Aoyagi,1800, Yamagata, 990-2292, Japan

Location

Related 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. doi: 10.1093/jjco/hyf085.

    PMID: 12417603BACKGROUND

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Mitsuru Sasako, MD, PhD

    Hyogo Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
JCOG Data Center

Study Record Dates

First Submitted

May 27, 2005

First Posted

May 30, 2005

Study Start

June 1, 2002

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

JP(35)