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

This study is currently recruiting participants.
Verified by Danish Head and Neck Cancer Group, December 2007

Sponsored by: 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

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

ChemIDplus related topics:   Cisplatin    Zalutumumab    Epidermal Growth Factor   

U.S. FDA Resources

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

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

  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.
  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

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

Responsible Party:   DAHANCA ( Jens Overgaard, professor, MD, )
Study ID Numbers:   DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486
First Received:   July 3, 2007
Last Updated:   December 20, 2007
ClinicalTrials.gov Identifier:   NCT00496652
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  

Study placed in the following topic categories:
Epidermoid carcinoma
Antibodies
Cisplatin
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 05, 2008




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