DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
This trial is active, not recruiting.
|Condition||cancer of the head and neck|
|Sponsor||Danish Head and Neck Cancer Group|
|Start date||November 2007|
|End date||July 2012|
|Trial size||600 participants|
|Trial identifier||NCT00496652, DAHANCA 19, DKMA: 2612-3486, Ethical Comittee: 20070091|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
time frame: 5 years
Disease-specific survival and overall control Acute and late toxicity
time frame: 5 years
Male or female participants at least 18 years old.
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
|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|
|Principal investigator||Jens Overgaard, Prof. MD|
|Description||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.|
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