Cancer of the Head and Neck Clinical Trial
Official title:
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
The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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