Clinical trial NCT00496652: DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer of the Head and Neck
Keywords: Squamous Cell Carcinomas of the Head and Neck
Epidermal Growth Factor receptor
Antibody
Radiotherapy
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
First posted: 2007-07-04
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
timeFrame: 5 years
Secondary outcomes:
measure: Disease-specific survival and overall control Acute and late toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Experimental Clinical Oncology, Aarhus University Hospital
Study officials:
affiliation: Danish Head and Neck Cancer Group (DAHANCA)
name: Jens Overgaard, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: