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

Danish Head and Neck Cancer Group

Status and phase: Completed; Phase 3

Conditions: Cancer of the Head and Neck

Treatments: Radiation: Radiotherapy; Drug: Zalutumumab

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00496652

DAHANCA 19

DKMA: 2612-3486

Ethical Comittee: 20070091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 619 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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619 participants in 2 patient groups

1

Active Comparator group

Description:

Radiotherapy (+cisplatin to stage 3+4)

Treatment:

Radiation: Radiotherapy

2

Experimental group

Description:

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)

Treatment:

Drug: Zalutumumab