DAHANCA 19: The Importance of the EGFr-Inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC - Full Text View

Sponsor:	Danish Head and Neck Cancer Group
Information provided by:	Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:	NCT00496652

Purpose

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	Intervention	Phase
Cancer of the Head and Neck	Radiation: Radiotherapy Drug: Zalutumumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Zalutumumab

U.S. FDA Resources

Further study details as provided by Danish Head and Neck Cancer Group:

Primary Outcome Measures:

Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2015

Arms	Assigned Interventions
1: Active Comparator 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)
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)	Drug: Zalutumumab Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496652

Contacts

Contact: Jens Overgaard, Prof., MD	+45 8949 2629	jens@oncology.dk
Contact: Jesper G. Eriksen, MD, PHD	+45 8949 2619	jesper@oncology.dk

Locations

Denmark
Department of Experimental Clinical Oncology, Aarhus University Hospital	Recruiting
Aarhus, Denmark, 8000 N
Contact: Jens Overgaard, Prof., MD +45 8949 2629 jens@oncology.dk
Contact: Jesper G. Eriksen, MD, PHD +89492619 jesper@oncology.dk

Sponsors and Collaborators

Danish Head and Neck Cancer Group

Investigators

Principal Investigator:

Jens Overgaard, Prof. MD

Danish Head and Neck Cancer Group (DAHANCA)

More Information

Additional Information:

official webpage of the Danish Head and Neck Cancer Group (DAHANCA) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	DAHANCA ( Jens Overgaard, professor, MD, )
Study ID Numbers:	DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486
Study First Received:	July 3, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00496652 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Danish Head and Neck Cancer Group:

Squamous Cell Carcinomas of the Head and Neck
Epidermal Growth Factor receptor
Antibody
Radiotherapy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Head and Neck Neoplasms

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 22, 2009