A phase II trial of neoadjuvant docetaxel/5-FU/cisplatin in combination with prophylactic Pegteograstim in unresectable, locally advanced nasal cavity/paranasal squamous cell carcinoma (SCC)
- Conditions
- Neoplasms
- Registration Number
- KCT0003377
- Lead Sponsor
- The Catholic University of Korea, St. Vincent's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall response rate
- Secondary Outcome Measures
Name Time Method progression-free survival;organ preservation rate at 24 months;safety