Clinical trial NCT00112099: GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Official title: Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Neoplasm
Keywords: gastric neoplasm
gastrectomy
splenectomy
randomized trial
T2, T3 and T4 carcinoma in the proximal third of the stomach
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: During the study conduct
Secondary outcomes:
measure: Post-operative morbidity
timeFrame: 5 years
measure: operation time
timeFrame: day of the operation
measure: perioperative blood loss
timeFrame: 3 days after operation
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Toyoake,Kutsukake-cho,Dengakugakubo,1-98
country: Japan
facility: Fujita Health University
state: Aichi
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Gifu,Kashima-cho,7-1
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Hiroshima,Naka-ku,Motomachi,7-33
country: Japan
facility: Hiroshima City Hospital
state: Hiroshima
city: Itami,Koyaike,1-100
country: Japan
facility: Itami City Hospital
state: Hyogo
city: Morioka,Uchimaru,19-1
country: Japan
facility: Iwate Medical University
state: Iwate
city: Kagoshima,Sakuragaoka,8-35-1
country: Japan
facility: Kagoshima University,Faculty of Medicine
state: Kagoshima
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5
country: Japan
facility: Kyoto Second Red Cross Hospital
state: Kyoto
city: Natori,Medeshima-Shiode,Nodayama,47-1
country: Japan
facility: Miyagi Cancer Center
state: Miyagi
city: Sendai,Miyagino-ku,Miyagino,2-8-8
country: Japan
facility: National Hospital Organization, Sendai Medical Center
state: Miyagi
city: Nagaoka,Kawasaki,2041
country: Japan
facility: Nagaoka Chuo General Hospital
state: Niigata
city: Niigata,Kawagishi-cho,2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Tsubame,Sawatari,633
country: Japan
facility: Tsubame Rosai Hospital
state: Niigata
city: Oita1-1,Hasama-machi,Oogaoka
country: Japan
facility: Oita University Fuculty of Medicine
state: Oita
city: Osaka,Chuo-ku,Hoenzaka,2-1-14
country: Japan
facility: Osaka National Hospital
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka-Sayama,Ohno-higashi,377-2
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai,Minamiyasuicho,1-1-1
country: Japan
facility: Sakai Municipal Hospital
state: Osaka
city: Takatsuki,Daigakucho,2-7
country: Japan
facility: Osaka Medical College
state: Osaka
city: Toyonaka,Shibaharacho,4-14-1
country: Japan
facility: Toyonaka Municipal Hospital
state: Osaka
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Tokorozawa,Namiki,3-2
country: Japan
facility: National Defense Medical College
state: Saitama
city: Shizuoka,Aoi-ku,Kitaando,4-27-1
country: Japan
facility: Shizuoka General Hospital
state: Sizuoka
city: Bunkyo-ku,Honkomagome,3-18-22
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Bunkyo-ku,Yushima,1-5-45
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku,Ariake,3-10-6
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Shinjuku-ku,Toyama,1-21-1
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Sumida-ku,Koutoubashi,4-23-15
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
state: Tokyo
city: Toyama,Nishinagae,2-2-78
country: Japan
facility: Toyama Prefectural Central Hospital
state: Toyama
city: Wakayama,Kimiidera,811-1
country: Japan
facility: Wakayama Medical University, School of Medicine
state: Wakayama
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: Hyogo Medical University
name: Mitsuru Sasako, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.