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:
Danish Head and Neck Cancer Group
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
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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 |
|---|---|---|
|
Cancer of the Head and Neck |
Radiation: Radiotherapy Drug: Zalutumumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Danish Head and Neck Cancer Group:
Primary Outcome Measures:
- Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease-specific survival and overall control Acute and late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496652
Locations
| Denmark | |
| Department of Experimental Clinical Oncology, Aarhus University Hospital | |
| Aarhus, Denmark, 8000 N | |
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
| Principal Investigator: | Jens Overgaard, Prof. MD | Danish Head and Neck Cancer Group (DAHANCA) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Danish Head and Neck Cancer Group |
| ClinicalTrials.gov Identifier: | NCT00496652 History of Changes |
| Other Study ID Numbers: | DAHANCA 19, Ethical Comittee: 20070091, DKMA: 2612-3486 |
| Study First Received: | July 3, 2007 |
| Last Updated: | July 1, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Danish Head and Neck Cancer Group:
|
Squamous Cell Carcinomas of the Head and Neck Epidermal Growth Factor receptor Antibody Radiotherapy |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013