None listed
Conditions
Interventions
Drug : Docetaxel 75 mg/m2, day 1 i.v.
cisplatin 75 mg/m2 day 1 i.v.
5-FU 1,000mg/m2 day1-4, i.v.
Pegteograstim 6mg day 6 or 7 s.c
every 3 weeks, until 3 cycles
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient have histrolocally or cytologically proven locally advanced squamous cell carcinoma (including undifferentiated carcinoma) arising from nasal cavity/paranasal sinus 2) At least one measurable disease, as defined by Response evaluation criteria in solid tumors (RECIST) version 1.1 3) in the opinion of the treating physician, it is impossible to achive complet resection or severely deteriorate patient's function or quailty of life if surgery is done. 4) =19 and =75 years 5) Eastern Cooperative Oncology Group (ECOG) 0 or1 6) adequate bone marrow, kidney, liver fuction 7) patients understand the trial and signed the informed consent
Exclusion criteria
Exclusion criteria: 1) patients have distant metastasis 2) pregnancy 3) prior chemotherapy or clinical trials within 30 days 4) prior treatment for head and neck cancer 5) = grade 2 peripheral neuropathy (Common Terminology Criteria for Adverse Events v. 5.0) 6) = grade 2 hearing impairment (Common Terminology Criteria for Adverse Events v. 5.0) 7) other unfit medical condition 8) genetic fluctose intolerance 9) latex allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;organ preservation rate at 24 months;safety | — |
Countries
Korea, Republic of
Contacts
Public ContactHo Jung An
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed