Cancer of the Head and NeckPhase 3NCT00496652
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
A Phase 3 study testing Radiotherapy and Zalutumumab in people with Cancer of the Head and Neck, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- Radiotherapy and Zalutumumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 619 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Rhinopharynx or carcinomas of unknown origin
- Distal metastases
- Other malignant diseases (prior or current) except from planocellular skin cancer
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, 8000 N
About this 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
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.
Read the 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.
- Conditions
- Cancer of the Head and Neck
- Being tested
- Radiotherapy, Zalutumumab
- Keywords
- Squamous Cell Carcinomas of the Head and Neck, Epidermal Growth Factor receptor, Antibody, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)
ZalutumumabDrug
Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Radiotherapy (+cisplatin to stage 3+4) Receives: Radiation: Radiotherapy |
| 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) Receives: Drug: Zalutumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
Measured: 5 years
Secondary outcomes (1)
Disease-specific survival and overall control Acute and late toxicity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2012
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens Overgaard, Prof. MD, Principal investigator, Danish Head and Neck Cancer Group (DAHANCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496652
- Sponsor's protocol ID
- DAHANCA 19
- Other IDs
- Ethical Comittee: 20070091, DKMA: 2612-3486
- Status last verified
- Nov 2016
- First submitted
- 3 Jul 2007
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eriksen JG, Maare C, Johansen J, Primdahl H, Bratland A, Kristensen CA, Andersen M, Alsner J, Overgaard J; DAHANCA. DAHANCA19: A randomized phase III study of primary curative (chemo)-radiotherapy and the EGFR-inhibitor zalutumumab for squamous cell carcinoma of the head and neck. Radiother Oncol. 2025 Jul;208:110899. doi: 10.1016/j.radonc.2025.110899. Epub 2025 Apr 19.
PubMed 40258418
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00496652
- Acronym / sponsor ID
- DAHANCA 19
- Conditions
- Cancer of the Head and Neck
- Keywords
- Squamous Cell Carcinomas of the Head and Neck, Epidermal Growth Factor receptor, Antibody, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- Nov 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: RadiotherapyRadiotherapy (+cisplatin to stage 3+4) |
| 2 | Experimental | Drug: ZalutumumabRadiotherapy 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Rhinopharynx or carcinomas of unknown origin
- Distal metastases
- Other malignant diseases (prior or current) except from planocellular skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4) | Radiation | 1 |
| ZalutumumabZalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose) | Drug | 2 |
Primary outcome
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab
Time frame: 5 years
1 secondary outcome
Disease-specific survival and overall control Acute and late toxicity
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Derived from this study: PubMed 40258418Eriksen JG, Maare C, Johansen J, Primdahl H, Bratland A, Kristensen CA, Andersen M, Alsner J, Overgaard J; DAHANCA. DAHANCA19: A randomized phase III study of primary curative (chemo)-radiotherapy and the EGFR-inhibitor zalutumumab for squamous cell carcinoma of the head and neck. Radiother Oncol. 2025 Jul;208:110899. doi: 10.1016/j.radonc.2025.110899. Epub 2025 Apr 19.
- official webpage of the Danish Head and Neck Cancer Group (DAHANCA)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Overgaard, Prof. MD principal investigator
Danish Head and Neck Cancer Group (DAHANCA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy and Zalutumumab in people with Cancer of the Head and Neck, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control after curative intended radiotherapy/chemoradiotherapy +/- zalutumumab (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00496652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.