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

Cancer of the Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496652
• Other study ID #: DAHANCA 19
• Secondary ID: Ethical Comittee
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2007
• Last updated: November 22, 2016
• Start date: November 2007
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Danish Head and Neck Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: November 2016
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
Denmark	Department of Experimental Clinical Oncology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Danish Head and Neck Cancer Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab		5 years	No
Secondary	Disease-specific survival and overall control Acute and late toxicity		5 years	Yes

External Links

•   official webpage of the Danish Head and Neck Cancer Group (DAHANCA)