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SOX as Salvage Treatment in Nasopharyngeal Carcinoma

This study has been terminated.
(poor accrual of eligible patients)
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01403259
First received: July 26, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose
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 Intervention Phase
Nasopharyngeal Carcinoma Drug: S-1 plus oxaliplatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Ye Guo, Fudan University:

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

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

Enrollment: 16
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403259

Locations
China
Fudan University Shanghai Cancer Center
Shanghai, China
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01403259     History of Changes
Other Study ID Numbers: HNTG 11-02
Study First Received: July 26, 2011
Last Updated: August 19, 2014

Keywords provided by Ye Guo, Fudan University:
Nasopharyngeal carcinoma
S-1
Oxaliplatin

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Oxaliplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017