Clinical trial · Interventional
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
NCT01090505CI-TRIAL-00003284unknownPhase 2ClinicalTrials.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 determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
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 Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: S-1 and oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
- description
- Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy
- interventionNames
- Drug: Drug: S-1 and oxaliplatin
- type
- NO_INTERVENTION
- label
- surgery
- description
- Procedure/Surgery: Gastrectomy with D2 dissection
- interventionNames
- Drug: Drug: S-1 and oxaliplatin
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 5 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. DISEASE CHARACTERISTICS: Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification) 2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy 3. Age:20 to 75 4. Performance status:ECOG 0-2 5. Life expectancy:Not specified 6. Hematopoietic:WBC 4,000-12,000/mm\^3；Granulocyte count ≥ 2,000/mm\^3；Platelet count ≥ 100,000/mm\^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL 7. Adequate organ function 8. Able to swallow oral medication 9. 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.