Clinical trial · Interventional
The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
NCT01531452CI-TRIAL-00016247completedPhase 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 the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| s1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- oxaliplatin+s1
- interventionNames
- Drug: Oxaliplatin
- Drug: s1
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 2 years
- description
- from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Secondary outcomes (3)
- measure
- Response Rate
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma * Measurable lesion and/or non-measurable lesion defined by RECIST * ECOG performance status ≦ 1 * Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3 * Creatine ≦ upper normal limit (UNL) * Total bilirubin ≦ 1.5 X UNL * AST, ALT and ALP ≦ 2.5 x UNL * Subjects must be able to take orally * No prior chemotherapy * Life expectancy estimated than 3 months * Written informed consent Exclusion Criteria: * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant * Known brain metastases * History of hypersensitivity to fluoropyrimidines, oxaliplatin * Active double cancer * Treatment with any investigational product during the last 4 weeks prior to study entry * Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0 * Any previous chemotherapy or radiotherapy for AGC
References
Publications (0)
Data not yet available
No reference posted for this study.