DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
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.
Cancer of the Head and Neck
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||November 2016|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Radiotherapy (+cisplatin to stage 3+4)
Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
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 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496652
|Department of Experimental Clinical Oncology, Aarhus University Hospital|
|Aarhus, Denmark, 8000 N|
|Principal Investigator:||Jens Overgaard, Prof. MD||Danish Head and Neck Cancer Group (DAHANCA)|