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: July 1, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 3, 2007

Last Updated Date

July 1, 2012

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Locoregional control after curative intended radiotherapy/chemoraiotherapy +/- zalutumumab [ Time Frame: 5 years ]

Change History

Complete list of historical versions of study NCT00496652 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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

The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
Whether disease-specific survival or overall survival is improved by addition of zalutumumab
Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
Acute and late toxicity to the treatment.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer of the Head and Neck

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

November 2016

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00496652

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Yes

Responsible Party

Danish Head and Neck Cancer Group

Study Sponsor ^ICMJE

Danish Head and Neck Cancer Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jens Overgaard, Prof. MD

Danish Head and Neck Cancer Group (DAHANCA)

Information Provided By

Danish Head and Neck Cancer Group

Verification Date

July 2012

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

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