poor accrual of eligible patients

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.

The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.

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