Clinical trial · Interventional
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501)
NCT00252161CI-TRIAL-00023971completedPhase 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 aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.
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 |
|---|---|---|---|
| Gastrectomy with more than D2 dissection | Procedure | — | UNRESOLVED |
| Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Procedure/Surgery: Gastrectomy with more than D2 dissection
- interventionNames
- Procedure: Gastrectomy with more than D2 dissection
- type
- EXPERIMENTAL
- label
- 2
- description
- Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
- interventionNames
- Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- during the study conduct
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically proven adenocarcinoma of stomach 2. Borrmann type 4 or large (\>=8 cm) type 3 3. no evidence of distant metastasis including liver(M0) 4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2) 5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation 6. no involvement of the esophagus with \> 3cm 7. an age of 20-75 years 8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 9. no prior chemotherapy, radiotherapy for any malignancy 10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR) 11. no breeding from primary tumor or gastrointestinal stenosis 12. sufficient oral intake 13. adequate organ function 14. written informed consent Exclusion Criteria: 1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2. pregnant or breast-feeding women 3. severe mental disease 4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease 6. myocardial infarction within six disease-free months
References
Publications (0)
Data not yet available
No reference posted for this study.