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
  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 3

Study Type: Interventional
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

Resource links provided by NLM:


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 2016
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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)
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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Department of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000 N
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:
No publications provided

Responsible Party: Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT00496652     History of Changes
Other Study ID Numbers: DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486
Study First Received: July 3, 2007
Last Updated: November 1, 2013
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:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on September 22, 2014