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

November 22, 2016 updated by: Danish Head and Neck Cancer Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

619

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000 N
        • Department of Experimental Clinical Oncology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-specific survival and overall control Acute and late toxicity
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Head and Neck Cancer Group

Investigators

  • Principal Investigator: Jens Overgaard, Prof. MD, Danish Head and Neck Cancer Group (DAHANCA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAHANCA 19
  • Ethical Comittee: 20070091
  • DKMA: 2612-3486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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