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

NCT ID: NCT00496652

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

619 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Cancer of the Head and Neck

Keywords

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Squamous Cell Carcinomas of the Head and Neck Epidermal Growth Factor receptor Antibody Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Radiotherapy (+cisplatin to stage 3+4)

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)

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)

Group Type EXPERIMENTAL

Zalutumumab

Intervention Type DRUG

Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Interventions

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Radiotherapy

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)

Intervention Type RADIATION

Zalutumumab

Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Head and Neck Cancer Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Overgaard, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Danish Head and Neck Cancer Group (DAHANCA)

Locations

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Department of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.dahanca.dk

official webpage of the Danish Head and Neck Cancer Group (DAHANCA)

Other Identifiers

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Ethical Comittee: 20070091

Identifier Type: -

Identifier Source: secondary_id

DKMA: 2612-3486

Identifier Type: -

Identifier Source: secondary_id

DAHANCA 19

Identifier Type: -

Identifier Source: org_study_id