DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck Whether disease-specific survival or overall survival is improved by addition of zalutumumab Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable Acute and late toxicity to the treatment.

Official Title
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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

Conditions
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Cancer of the Head and Neck

Intervention / Treatment
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* Radiation: Radiotherapy
* Drug: Zalutumumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Radiotherapy (+cisplatin to stage 3+4) | Radiation: Radiotherapy<br>* Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)<br>|
| Experimental: 2<br>Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4) + Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose) | Drug: Zalutumumab<br>* Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific survival and overall control Acute and late toxicity |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous Cell Carcinomas of the Head and Neck, Epidermal Growth Factor receptor, Antibody, Radiotherapy