SOX as Salvage Treatment in Nasopharyngeal Carcinoma

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01403259

Enrollment

Registered

2011-07-27

Start date

2011-07-31

Completion date

2015-12-31

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, S-1, Oxaliplatin

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 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.

Interventions

DRUGS-1 plus oxaliplatin

S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Median progression-free survival	1 year

Secondary

Measure	Time frame
Overall response rate	6 weeks
Median overall survival	1.5 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026