Trial | NCT00496652  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    zalutumumab ...

  • Study Participants

    619
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.
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 Started
Nov 30
2007
Primary Completion
Jul 31
2012
Study Completion
Nov 30
2016
Last Update
Nov 25
2016
Estimate

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)

1 Active Comparator

Radiotherapy (+cisplatin to stage 3+4)

2 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)

Criteria 

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
No Results Posted