SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: S-1 plus oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 plus oxaliplatin<br>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 | Drug: S-1 plus oxaliplatin<br>* S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks<br>* Other names: Oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression-free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 6 weeks | 
| Median overall survival |  | 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, S-1, Oxaliplatin