Locally Advanced Head and Neck CancerPhase 2NCT02976051
DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC
A Phase 2 study testing HART-CN in people with Locally Advanced Head and Neck Cancer and Radiotherapy, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
Trial summary
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Cancer, Radiotherapy, Hypoxic Radioresistance
- What is being tested?
- HART-CN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to Apr 2023
- Phase
- Phase 2
- 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
- Stage III-IV larynx, pharynx, oral cavity
- Hypoxic FAZA-PET positive
- Indication for primary radio-chemotherapy
- Informed consent
Who cannot join
- HPV positive oropharynx cancer
- Primary surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, 8000 C
About this study
Official title: DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning
Read the detailed description
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.
Inclusion:
Patients must fulfill the following:
Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole
- Being tested
- HART-CN
- 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.
HART-CNRadiation
HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole
| Study group | Role | What they receive |
|---|---|---|
| Treatment with HART-CN | Experimental | HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole Receives: Radiation: HART-CN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional failure
loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).
Measured: Year 3
Secondary outcomes (4)
Overall survival
Death from all causes
Measured: Year 3
Acute radiation related morbidity
Measured: Month 3
Late radiation related morbidity
Measured: Year 3
Disease-specific death
Disease-specific death is defined as death from or with the cancer in question;
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2021
- Study completionApr 2023
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 Locally Advanced Head and Neck CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Jens Overgaard, Danish Head and Neck Cancer Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976051
- Sponsor's protocol ID
- DAHANCA 33
- Status last verified
- Apr 2023
- First submitted
- 22 Nov 2016
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.
PubMed 23083497
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02976051
- Acronym / sponsor ID
- DAHANCA 33
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 29 Nov 2016 (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.
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning
Detailed description
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.
Inclusion:
Patients must fulfill the following:
Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with HART-CN | Experimental | Radiation: HART-CNHART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage III-IV larynx, pharynx, oral cavity
- Hypoxic FAZA-PET positive
- Indication for primary radio-chemotherapy
- Informed consent
Key exclusion criteria (2 listed)
- HPV positive oropharynx cancer
- Primary surgery
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 |
|---|---|---|
| HART-CNHART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole | Radiation | Treatment with HART-CN |
Primary outcome
Loco-regional failure
Time frame: Year 3
loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).
4 secondary outcomes
Overall survival
Time frame: Year 3
Acute radiation related morbidity
Time frame: Month 3
Late radiation related morbidity
Time frame: Year 3
Disease-specific death
Time frame: Year 3
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 2 Nov 2026.
- Results publication: PubMed 23083497Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HART-CN in people with Locally Advanced Head and Neck Cancer and Radiotherapy, 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 4 inclusion and 2 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 2 Nov 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Loco-regional failure (time frame: Year 3). 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 NCT02976051, 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 2 Nov 2026.