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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496652
First Posted: July 4, 2007
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danish Head and Neck Cancer Group
July 3, 2007
July 4, 2007
November 25, 2016
November 2007
July 2012   (Final data collection date for primary outcome measure)
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ]
Locoregional control after curative intended radiotherapy/chemoraiotherapy +/- zalutumumab [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00496652 on ClinicalTrials.gov Archive Site
Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
 
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
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

  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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer of the Head and Neck
  • 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)
  • Active Comparator: 1
    Radiotherapy (+cisplatin to stage 3+4)
    Intervention: Radiation: Radiotherapy
  • Experimental: 2
    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)
    Intervention: Drug: Zalutumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
619
November 2016
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00496652
DAHANCA 19
Ethical Comittee: 20070091
DKMA: 2612-3486
Yes
Not Provided
Not Provided
Danish Head and Neck Cancer Group
Danish Head and Neck Cancer Group
Not Provided
Principal Investigator: Jens Overgaard, Prof. MD Danish Head and Neck Cancer Group (DAHANCA)
Danish Head and Neck Cancer Group
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP