Head and Neck Squamous Cell CarcinomaPhase 3DAHANCA30NCT02661152
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
A Phase 3 study testing Nimorazole in people with Head and Neck Squamous Cell Carcinoma and Radiotherapy, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
Trial summary
Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC). In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been possible to discriminate more hypoxic tumours from less… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Radiotherapy, Hypoxic Modification
- What is being tested?
- Nimorazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,252 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Dec 2024
- 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
- Head and neck squamous cell carcinoma with indication for hypoxic modification with nimorazole in accordance to the Danish Head and Neck Cancer guidelines (DAHANCA guidelines).
- Informed consent
Who cannot join
- Previous or present malignant disease conflicting with the radiotherapy treatment or evaluation of the treatment.
- Participation in a conflicting protocol.
- Initiation of radiotherapy more than 3 weeks after inclusion
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 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification With Nimorazole During Radiotherapy/Chemoradiotherapy of Squamous Cell Carcinoma of the Head and Neck.
Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).
In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been possible to discriminate more hypoxic tumours from less hypoxic tumours.
A hypoxia gene profile has shown to discriminate between responders and non-responders to nimorazole.
In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/- nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.
Read the detailed description
Hypoxic modification of radiotherapy with nimorazole has in the DAHANCA 5 trial been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).
Previously, it has not been possible to discriminate more hypoxic tumours from less hypoxic tumours. Thus, nimorazole has been added the radiotherapy of most HNSCC.
Recently, a hypoxia gene profile has been developed, that discriminate between more and less hypoxic tumours. The basis of the discrimination is the cumulated expression of 15 hypoxia responsive genes, quantified from the tumour biopsy.
The profile has been validated on the independent DAHANCA 5 cohort. There was a significant effect of adding nimorazole to the radiotherapy of more hypoxic tumours as estimated with the gene profile, whereas there was no effect of adding nimorazole to the less hypoxic tumours. In a test for interaction, there was a significantly different response to nimorazole in the more hypoxic tumours compared to the less hypoxic tumours.
In the Dahanca 30 trial it is aimed to verify, that there is no benefit of supplying the radiotherapy of less hypoxic HNSCC with nimorazole. Thus, to explore whether it is possible to avoid the sideeffects of nimorazole without risk for the patient.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Radiotherapy, Hypoxic Modification, Hypoxia, Gene Profile, Gene Signature
- Being tested
- Nimorazole
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimorazoleDrug
Hypoxia gene profile is expected to discriminate between HNSCC responders and non-responders to hypoxic modification with nimorazole during radiotherapy. In DAHANCA 30 expected non-responders are randomized to +/- nimorazole during radiotherapy (non-inferiority study). Thus, similar efficacy of radiotherapy is expected in these groups. More hypoxic tumours receive nimorazole after DAHANCA standards.
| Study group | Role | What they receive |
|---|---|---|
| Radio-/Chemoradiotherapy + nimorazole | Experimental | Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole but receiving the drug, which is normal standard radiotherapy of HNSCC in Denmark. Receives: Drug: Nimorazole |
| Radio-/Chemoradiotherapy | No intervention | Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole and not receiving the drug, that is normally part of standard radiotherapy of HNSCC in Denmark. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with locoregional tumour control
Patients are being followed with regular clinical examinations for 5 years after therapy. Side effects, tumour control and survival status is registered in the DAHANCA database. Interim analysis are planned every 12 months.
Measured: 5 years
Secondary outcomes (1)
Number of participants with disease specific survival
Patients are being followed with regular clinical examinations for 5 years after therapy. Side effects, tumour control and survival status is registered in the DAHANCA database. Interim analysis are planned every 12 months.
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 posted22 Jan 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2024
- Study completionDec 2024
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 Head and Neck Squamous Cell CarcinomaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens Overgaard, MD DMSc, Study chair, DAHANCA Danish Head and Neck Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661152
- Sponsor's protocol ID
- DAHANCA 30
- Acronym
- DAHANCA30
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2016
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wind KL, Alsner J, Krag SP, Stribolt K, Lefevre AC, Toustrup K, Sorensen BS, Overgaard J, Spindler KG. Hypoxia-induced radioresistance in squamous cell carcinoma of the anus treated with radiotherapy - a validating study. Radiother Oncol. 2025 Nov;212:111118. doi: 10.1016/j.radonc.2025.111118. Epub 2025 Aug 30.
PubMed 40889642
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 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification With Nimorazole During Radiotherapy/Chemoradiotherapy of Squamous Cell Carcinoma of the Head and Neck.
- ClinicalTrials.gov ID
- NCT02661152
- Acronym / sponsor ID
- DAHANCA30 / DAHANCA 30
- Conditions
- Head and Neck Squamous Cell Carcinoma, Radiotherapy, Hypoxic Modification, Hypoxia, Gene Profile, Gene Signature
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,252 participants (estimated)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 22 Jan 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.
Hypoxic modification of radiotherapy with nimorazole has previously been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).
In Denmark, nimorazole is added the radiotherapy of most HNSCC, as it has not previously been possible to discriminate more hypoxic tumours from less hypoxic tumours.
A hypoxia gene profile has shown to discriminate between responders and non-responders to nimorazole.
In DAHANCA 30, expected hypoxia profile guided non-responders are randomized to +/- nimorazole during radiotherapy.This in order to verify clinical use of the gene profile in selecting the relevant patients for hypoxic modification of radiotherapy with nimorazole.
Detailed description
Hypoxic modification of radiotherapy with nimorazole has in the DAHANCA 5 trial been shown to increase radiosensitivity in hypoxic head and neck squamous cell carcinomas (HNSCC).
Previously, it has not been possible to discriminate more hypoxic tumours from less hypoxic tumours. Thus, nimorazole has been added the radiotherapy of most HNSCC.
Recently, a hypoxia gene profile has been developed, that discriminate between more and less hypoxic tumours. The basis of the discrimination is the cumulated expression of 15 hypoxia responsive genes, quantified from the tumour biopsy.
The profile has been validated on the independent DAHANCA 5 cohort. There was a significant effect of adding nimorazole to the radiotherapy of more hypoxic tumours as estimated with the gene profile, whereas there was no effect of adding nimorazole to the less hypoxic tumours. In a test for interaction, there was a significantly different response to nimorazole in the more hypoxic tumours compared to the less hypoxic tumours.
In the Dahanca 30 trial it is aimed to verify, that there is no benefit of supplying the radiotherapy of less hypoxic HNSCC with nimorazole. Thus, to explore whether it is possible to avoid the sideeffects of nimorazole without risk for the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio-/Chemoradiotherapy + nimorazole | Experimental | Drug: NimorazoleHypoxia profile guided non-responder (less hypoxic tumour) to nimorazole but receiving the drug, which is normal standard radiotherapy of HNSCC in Denmark. |
| Radio-/Chemoradiotherapy | No intervention | –Hypoxia profile guided non-responder (less hypoxic tumour) to nimorazole and not receiving the drug, that is normally part of standard radiotherapy of HNSCC in Denmark. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Head and neck squamous cell carcinoma with indication for hypoxic modification with nimorazole in accordance to the Danish Head and Neck Cancer guidelines (DAHANCA guidelines).
- Informed consent
Key exclusion criteria (3 listed)
- Previous or present malignant disease conflicting with the radiotherapy treatment or evaluation of the treatment.
- Participation in a conflicting protocol.
- Initiation of radiotherapy more than 3 weeks after inclusion
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 |
|---|---|---|
| NimorazoleHypoxia gene profile is expected to discriminate between HNSCC responders and non-responders to hypoxic modification with nimorazole during radiotherapy. In DAHANCA 30 expected non-responders are randomized to +/- nimorazole during radiotherapy (non-inferiority study). Thus, similar efficacy of radiotherapy is expected in these groups. More hypoxic tumours receive nimorazole after DAHANCA standards. | Drug | Radio-/Chemoradiotherapy + nimorazole |
Primary outcome
Number of participants with locoregional tumour control
Time frame: 5 years
Patients are being followed with regular clinical examinations for 5 years after therapy. Side effects, tumour control and survival status is registered in the DAHANCA database. Interim analysis are planned every 12 months.
1 secondary outcome
Number of participants with disease specific survival
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 2 Nov 2026.
- Derived from this study: PubMed 40889642Wind KL, Alsner J, Krag SP, Stribolt K, Lefevre AC, Toustrup K, Sorensen BS, Overgaard J, Spindler KG. Hypoxia-induced radioresistance in squamous cell carcinoma of the anus treated with radiotherapy - a validating study. Radiother Oncol. 2025 Nov;212:111118. doi: 10.1016/j.radonc.2025.111118. Epub 2025 Aug 30.
- 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.
Jens Overgaard, MD DMSc study chair
DAHANCA Danish Head and Neck Group
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 Nimorazole in people with Head and Neck Squamous Cell Carcinoma 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 2 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 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 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?
Number of participants with locoregional tumour control (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 NCT02661152, 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.