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

• ClinicalTrials.gov Identifier: NCT00112099
• Recruitment Status: Completed
• First Posted: May 30, 2005
• Last Update Posted: September 22, 2016
• Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Information provided by (Responsible Party): Haruhiko Fukuda, Japan Clinical Oncology Group

Tracking Information

• First Submitted Date: May 27, 2005
• First Posted Date: May 30, 2005
• Last Update Posted Date: September 22, 2016
• Study Start Date: June 2002
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 29, 2008): Overall survival [ Time Frame: During the study conduct ]
• Original Primary Outcome Measures (submitted: June 23, 2005): Overall survival

Current Secondary Outcome Measures (submitted: February 29, 2008)

• Post-operative morbidity [ Time Frame: 5 years ]
• operation time [ Time Frame: day of the operation ]
• perioperative blood loss [ Time Frame: 3 days after operation ]

Original Secondary Outcome Measures (submitted: June 23, 2005)

• Post-operative morbidity
• operation time
• perioperative blood loss

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Neoplasm

Intervention

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

Study Arms

• Active Comparator: 1
  Procedure/Surgery: Surgery: Splenectomy
  Intervention: Procedure: Surgery: Splenectomy
• Experimental: 2
  Procedure/Surgery: Surgery: Spleen-preservation
  Intervention: Procedure: Surgery: Spleen-preservation

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2005): 500
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00112099
• Other Study ID Numbers: JCOG 0110; C000000004
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Haruhiko Fukuda, Japan Clinical Oncology Group
• Study Sponsor: Haruhiko Fukuda
• Collaborators: Ministry of Health, Labour and Welfare, Japan

Investigators

• Study Chair: Mitsuru Sasako, MD, PhD; Hyogo College of Medicine

• PRS Account: Japan Clinical Oncology Group
• Verification Date: September 2016