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SOX as Salvage Treatment in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403259
Recruitment Status : Terminated (poor accrual of eligible patients)
First Posted : July 27, 2011
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
Ye Guo, 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: S-1 plus oxaliplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma
Study Start Date : July 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: 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
Drug: 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 Names:
  • S-1
  • Oxaliplatin

Primary Outcome Measures :
  1. Median progression-free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 6 weeks ]
  2. Median overall survival [ Time Frame: 1.5 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01403259

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Fudan University Shanghai Cancer Center
Shanghai, China
Sponsors and Collaborators
Fudan University
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Principal Investigator: Ye Guo, MD Fudan University
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Responsible Party: Ye Guo, Dr., Fudan University Identifier: NCT01403259    
Other Study ID Numbers: HNTG 11-02
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Ye Guo, Fudan University:
Nasopharyngeal carcinoma
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents