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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer of the Head and Neck

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Jens Overgaard, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Danish Head and Neck Cancer Group (DAHANCA)

Authority:

Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:

DAHANCA 19

NCT ID:

NCT00496652

Start Date:

November 2007

Completion Date:

November 2016

Related Keywords:

  • Cancer of the Head and Neck
  • Squamous Cell Carcinomas of the Head and Neck
  • Epidermal Growth Factor receptor
  • Antibody
  • Radiotherapy
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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