INDUCTION CHEMOTHERAPY FOLLOWED BY RADIOTHERAPY CONCOMITANT TO CETUXIMAB IN HEAD AND NECK SQUAMOUS CELL CARCINOMA: PHASE II STUDY - ND
- Conditions
- head and neck squamous cell carcinomaMedDRA version: 9.1Level: HLTClassification code 10046311Term: Upper respiratory tract neoplasms
- Registration Number
- EUCTR2007-004099-38-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
istologically proven HNSCC
age over 18 and under 75
PS ECOG 0-2
stage III - IV
neoplasia unfit for surgery
medical controindication for surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
distant MTS
previous chemotherapy and/or radiotherapy
general condition that controindicate chemotheraphy or radiotherapy
ischemic heart disease or heart failure in the last six months
active infectious disease
sensitive neuropathy grade to or more
previous malignmant disease except cervical carcinoma, cutaneous basalioma or any other with more than five years follow up
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: toxicity<br><br>locoregional control rate;Secondary Objective: disease free survival<br><br>overall survival<br><br>distant metastasis pattern<br><br>predictive biological parameters;Primary end point(s): complete and parzial response rate<br><br>toxicity
- Secondary Outcome Measures
Name Time Method