Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
18 Years
75 Years
Both
Head and Neck Cancer
Trial Information
Induction by Docetaxel/Cisplatin/5-Fluorouracil (TCF) Prior to Radiotherapy With Concomintant Cetuximab in Locally Advanced Inoperable Head and Neck Tumours - a Methodical Trial
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5
as continuous i.v. infusion, Duration of 1 cycle: 21 days;
Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application
of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8
applications of Cetuximab.
Inclusion Criteria:
- histologically confirmed, locally advanced head and neck cancer
- stage III/IV
- performance status: ECOG 0-1
Exclusion Criteria:
- distant metastases
- prior radiotherapy of the head and neck region
- myocardial infarct in the last six months
- florid peptic ulcer
- neuropathy grade III/IV
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
locoregional tumour control
Principal Investigator
Felix Keil, MD
Investigator Role:
Study Chair
Investigator Affiliation:
LKH Leoben, Dept. for Hemato-Oncology
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
ASOG-HNO1
NCT ID:
NCT00502463
Start Date:
June 2007
Completion Date:
December 2013
Related Keywords:
- Head and Neck Cancer
- head and neck cancer, stage III/IV
- no prior radiotherapy of head and neck region
- Head and Neck Neoplasms
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