phase II trial of concurrent chemoradiotherapy (CCRT) with docetaxel + cisplatin + cetuximab for locally advanced squamous cell carcinoma of the head and neck
Phase 2
- Conditions
- advanced squamous cell carcinoma of the head and neck
- Registration Number
- JPRN-UMIN000013858
- Lead Sponsor
- Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) with distant metastasis 2) nasopharyngeal cancer 3) post-operative chemoradiotherapy 4) with treatment history of cetuximab or with allergy to taxan, platinum analogue, or cetuximab or with a history of allergy 5) creatinin clearance < 65ml/min 6) with heart disease which is difficult to control 7) with interstitial pneumonitis or pulmonary fibrosis 8) with diabetic, hypertension, or liver dysfunction which is difficult to control 9) with infection which need to treat 10) with severe drug allergy 11) pregnant, women who like be pregnant, or man who doesn't agree to contraception during the treatment 12) doctor's decision not to be registered to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety acute adverse event (neutropenia) during primary treatment
- Secondary Outcome Measures
Name Time Method response rate, treatment comprehensive rate, disease-free survival, Overall survival