Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2011-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Ye Guo
Dr.
Principal Investigators
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Ye Guo, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Other Identifiers
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HNTG 11-02
Identifier Type: -
Identifier Source: org_study_id
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