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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:
NCT00496652
First received: July 3, 2007
Last updated: November 1, 2013
Last verified: November 2013

July 3, 2007
November 1, 2013
November 2007
July 2012   (final data collection date for primary outcome measure)
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
600
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00496652
DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486
Yes
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 2013

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