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.
Status | Completed |
Enrollment | 619 |
Est. completion date | November 2016 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx) - Curative intent and no prior treatment - Age > 18 years - WHO performance 0-2 (incl.) - No prior treatment with EGFr-I - Informed consent according to local guidelines and national law - The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up - Fertile women must use contraceptive devices (IUD or oral contraceptives) Exclusion Criteria: - Rhinopharynx or carcinomas of unknown origin - Distal metastases - Other malignant diseases (prior or current) except from planocellular skin cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Experimental Clinical Oncology, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Danish Head and Neck Cancer Group |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab | 5 years | No | |
Secondary | Disease-specific survival and overall control Acute and late toxicity | 5 years | Yes |
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