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Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Phase 2
18 Years
75 Years
Open (Enrolling)
Nasopharyngeal Carcinoma

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Trial Information

Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median progression-free survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:

HNTG 11-02



Start Date:

July 2011

Completion Date:

December 2013

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal carcinoma
  • S-1
  • Oxaliplatin
  • Carcinoma
  • Nasopharyngeal Neoplasms