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