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

Phase 3

Completed

• Conditions: Cancer of the Head and Neck
• Interventions: Radiation: Radiotherapy; Drug: Zalutumumab

• Registration Number: NCT00496652
• Lead Sponsor: Danish Head and Neck Cancer Group

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.

Study Timeline

• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2007-11
• Primary Completion: 2012-07
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Radiotherapy	Radiotherapy (+cisplatin to stage 3+4)
2	Zalutumumab	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)

Primary Outcome Measures

Name	Time	Method
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab	5 years

Secondary Outcome Measures

Name	Time	Method
Disease-specific survival and overall control Acute and late toxicity	5 years

Trial Locations

Locations (1)

Department of Experimental Clinical Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark