Overview

This trial has been completed.

Condition cancer of the head and neck
Treatments radiotherapy, zalutumumab
Phase phase 3
Sponsor Danish Head and Neck Cancer Group
Start date November 2007
End date July 2012
Trial size 619 participants
Trial identifier NCT00496652, DAHANCA 19, DKMA: 2612-3486, Ethical Comittee: 20070091

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Radiotherapy (+cisplatin to stage 3+4)
radiotherapy
Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
(Experimental)
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)
zalutumumab
Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jens Overgaard, Prof. MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Danish Head and Neck Cancer Group.