Clinical trial · Interventional
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
NCT00112099CI-TRIAL-00023995completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Neoplasm | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery: Spleen-preservation | Procedure | — | UNRESOLVED |
| Surgery: Splenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Procedure/Surgery: Surgery: Splenectomy
- interventionNames
- Procedure: Surgery: Splenectomy
- type
- EXPERIMENTAL
- label
- 2
- description
- Procedure/Surgery: Surgery: Spleen-preservation
- interventionNames
- Procedure: Surgery: Spleen-preservation
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- During the study conduct
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.References
Publications (1)
- BACKGROUNDSano 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 12417603