Clinical trial · Interventional
SOX as Salvage Treatment in Nasopharyngeal Carcinoma
Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma
NCT01403259CI-TRIAL-00015421terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual of eligible patients
Summary
Brief summary (as posted)
The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 plus oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 plus oxaliplatin
- description
- S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles
- interventionNames
- Drug: S-1 plus oxaliplatin
Primary outcomes (1)
- measure
- Median progression-free survival
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Overall response rate
- timeFrame
- 6 weeks
- measure
- Median overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age range: 18-75 years old * Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma * Prior exposure of at least one line of platinum-containing regimen * ECOG performance status 0-1 * Life expectancy of more than 3 months * Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L * Liver function: total bilirubin, ALT and AST \<1.5×UNL * Renal function: Cr\<1.5×UNL, CCR≧50ml/min * Without \> 1 grade of neuropathy Exclusion Criteria: * With curable treatment option * With CNS involvement * Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy * Treated with \> 2 lines of palliative chemotherapy * With prior exposure of S-1 or oxaliplatin * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Significant active infection * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.