DAHANCA 19: A Randomized Study of the Importance of the EGFr-Inhibitor Zalutumumab for the Outcome After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the
last decades by altered fractionation, the addition of concomitant chemotherapy or
modification of hypoxia. By these modifications the locoregional control, disease-specific
survival or overall survival have been increased but the price have been increased
morbidity.
The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further
increase the control and survival of patients with Squamous Cell Carcinomas of the Head and
Neck when combined with radiotherapy and/or chemotherapy.
The aim of the present study is to determine whether
1. The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell
Carcinomas of the Head and Neck
2. Whether disease-specific survival or overall survival is improved by addition of
zalutumumab
3. Whether the addition of zalutumumab to primary curative radiotherapy or
chemoradiotherapy is feasible and tolerable
4. Acute and late toxicity to the treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
5 years
No
Jens Overgaard, Prof. MD
Principal Investigator
Danish Head and Neck Cancer Group (DAHANCA)
Denmark: The Danish National Committee on Biomedical Research Ethics
DAHANCA 19
NCT00496652
November 2007
November 2016
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