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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00496652

Enrollment

619

Registered

2007-07-04

Start date

2007-11-30

Completion date

2016-11-30

Last updated

2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Head and Neck

Keywords

Squamous Cell Carcinomas of the Head and Neck, Epidermal Growth Factor receptor, Antibody, Radiotherapy

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.

Interventions

RADIATIONRadiotherapy

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)

DRUGZalutumumab

Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab	5 years

Secondary

Measure	Time frame
Disease-specific survival and overall control Acute and late toxicity	5 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026