Status:
TERMINATED
SOX as Salvage Treatment in Nasopharyngeal Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
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 ne...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01403259
Start Date
July 1 2011
End Date
December 1 2015
Last Update
August 20 2014
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China