SOX as Salvage Treatment in Nasopharyngeal Carcinoma

NCT ID: NCT01403259

Last Updated: 2014-08-20

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-12-31

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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

S-1 plus oxaliplatin

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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S-1 Oxaliplatin

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ye Guo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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HNTG 11-02

Identifier Type: -

Identifier Source: org_study_id

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