SOX as Salvage Treatment in Nasopharyngeal Carcinoma

NCT01403259 | Terminated Phase 2

• 1 other identifier: HNTG 11-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; S-1; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival

  1 year

Secondary Outcomes (2)

• Overall response rate

  6 weeks

• Median overall survival

  1.5 year

Study Arms (1)

S-1 plus oxaliplatin

EXPERIMENTAL

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

Interventions

S-1 plus oxaliplatin DRUG

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

Also known as: S-1, Oxaliplatin

S-1 plus oxaliplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Ye Guo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

CN (1)