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| Sponsored by: |
Danish Head and Neck Cancer Group |
| Information provided by: | Danish Head and Neck Cancer Group |
| ClinicalTrials.gov Identifier: | NCT00496652 |
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 |
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Cancer of the Head and Neck |
Radiation: Radiotherapy Drug: Zalutumumab |
Phase III |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| ChemIDplus related topics: | Cisplatin Zalutumumab Epidermal Growth Factor |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2015 |
| Arms | Assigned Interventions |
|
1: Active Comparator
Radiotherapy (+cisplatin to stage 3+4)
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Radiation: Radiotherapy
Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
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2: Experimental
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)
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Drug: Zalutumumab
Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)
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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
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jens Overgaard, Prof., MD | +45 8949 2629 | jens@oncology.dk |
| Contact: Jesper G. Eriksen, MD, PHD | +45 8949 2619 | jesper@oncology.dk |
| Denmark | |||||
| Department of Experimental Clinical Oncology, Aarhus University Hospital | Recruiting | ||||
| Aarhus, Denmark, 8000 N | |||||
| Contact: Jens Overgaard, Prof., MD +45 8949 2629 jens@oncology.dk | |||||
| Contact: Jesper G. Eriksen, MD, PHD +89492619 jesper@oncology.dk | |||||
| Danish Head and Neck Cancer Group |
| Principal Investigator: | Jens Overgaard, Prof. MD | Danish Head and Neck Cancer Group (DAHANCA) |
More Information
official webpage of the Danish Head and Neck Cancer Group (DAHANCA) 
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| Responsible Party: | DAHANCA ( Jens Overgaard, professor, MD, ) |
| Study ID Numbers: | DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486 |
| First Received: | July 3, 2007 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00496652 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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