SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Phase 2

Terminated

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: S-1 plus oxaliplatin

• Registration Number: NCT01403259
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 plus oxaliplatin	S-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 for 6 cycles

Primary Outcome Measures

Name	Time	Method
Median progression-free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Overall response rate	6 weeks
Median overall survival	1.5 year

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China