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

Sponsor

Danish Head and Neck Cancer Group (Other)

Overall Status

Completed

CT.gov ID

NCT00496652

Collaborator

(none)

619

Enrollment

Location

Arms

108

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Head and Neck	Radiation: Radiotherapy Drug: Zalutumumab	Phase 3

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

The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
Whether disease-specific survival or overall survival is improved by addition of zalutumumab
Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
Acute and late toxicity to the treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

619 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Radiotherapy (+cisplatin to stage 3+4)	Radiation: Radiotherapy Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
Experimental: 2 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)	Drug: Zalutumumab Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Arm

Intervention/Treatment

Active Comparator: 1

Radiotherapy (+cisplatin to stage 3+4)

Radiation: Radiotherapy

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

Experimental: 2

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)

Drug: Zalutumumab

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

Outcome Measures

Primary Outcome Measures

Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [5 years]

Secondary Outcome Measures

Disease-specific survival and overall control Acute and late toxicity [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)