Overview

SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Status:
Terminated
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Oxaliplatin
Criteria
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