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

Sponsor:	Japan Clinical Oncology Group
Collaborator:	Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00112099

Purpose

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.

Condition	Intervention	Phase
Gastric Neoplasm	Procedure: Surgery: Splenectomy Procedure: Surgery: Spleen-preservation	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer Surgery

U.S. FDA Resources

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-operative morbidity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
operation time [ Time Frame: day of the operation ] [ Designated as safety issue: Yes ]
perioperative blood loss [ Time Frame: 3 days after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	June 2002
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Procedure/Surgery: Surgery: Splenectomy	Procedure: Surgery: Splenectomy Procedure/Surgery: Surgery: Splenectomy
2: Experimental Procedure/Surgery: Surgery: Spleen-preservation	Procedure: Surgery: Spleen-preservation Procedure/Surgery: Surgery: Spleen-preservation

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

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112099

Show 35 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Mitsuru Sasako, MD, PhD

Hyogo College of Medicine

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Japan Clinical Oncology Group ( Mitsuru Sasako, MD, PhD )
Study ID Numbers:	JCOG 0110, C000000004
Study First Received:	May 27, 2005
Last Updated:	August 2, 2009
ClinicalTrials.gov Identifier:	NCT00112099 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

gastric neoplasm
gastrectomy
splenectomy
randomized trial
T2, T3 and T4 carcinoma in the proximal third of the stomach

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 20, 2009