Head & Neck Squamous Cell CarcinomaDART-HNNCT07506902
A Study of Adaptive Radiotherapy of Head-neck Cancer Using Daily Replanning and Optimization of the Treatment Plan.
A study testing Daily online adaptive radiotherapy in people with Head & Neck Squamous Cell Carcinoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Radiotherapy of head-neck cancer is associated with significant side effects. Using daily online adaptive radiotherapy to account for the changing anatomy, radiation to organs at risk can be lowered. We will investigate whether this is feasible and associated with a reduction in the risk of toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Squamous Cell Carcinoma
- What is being tested?
- Daily online adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer Informed consent as required by law The patient cannot participate in conflicting protocols Stage I-IV (excluding T1-T2N0 carcinoma of the glottic larynx) ECOG/WHO performance status 0-2
Who cannot join
- Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area and unknown primary tumor.
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic Distant metastasis Previous radiotherapy of the head and neck Previous surgery for the primary cancer with curative intent
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Jeppe Friborg, MD, PhD, +45 35458189, jeppe.friborg@regionh.dk
Anne Lindegaard, MD, +45 35456107, anne.marie.mira.lindegaard@regionh.dk
About this study
Official title: DART-HN - Daily Adaptive Radiotherapy of Head-neck Cancer.
Radiotherapy of head-neck cancer is associated with significant side effects. Using daily online adaptive radiotherapy to account for the changing anatomy, radiation to organs at risk can be lowered. We will investigate whether this is feasible and associated with a reduction in the risk of toxicity.
- Conditions
- Head & Neck Squamous Cell Carcinoma
- Being tested
- Daily online adaptive radiotherapy
- Keywords
- Head and neck cancer, Adaptive radiotherapy, Online adaptive radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily online adaptive radiotherapyRadiation
The patients will undergo daily online adaptive re-optimisation of the radiotherapy treatment plan following daily recontouring.
| Study group | Role | What they receive |
|---|---|---|
| Daily online adaptive radiotherapy for head and neck cancer | Experimental | Patients will undergo daily online adaptive radiotherapy for all fractions in the treatment course. The treatment plan will be re-optimised following recontouring on a daily basis using the Siemens-Varian Ethos Platform. Receives: Radiation: Daily online adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of dysphagia and xerostomia six months post-treatment assesed by normal-tissue complication probability (NTCP) models
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start21 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeppe Friborg, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506902
- Sponsor's protocol ID
- 2202672
- Acronym
- DART-HN
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DART-HN - Daily Adaptive Radiotherapy of Head-neck Cancer.
- ClinicalTrials.gov ID
- NCT07506902
- Acronym / sponsor ID
- DART-HN / 2202672
- Conditions
- Head & Neck Squamous Cell Carcinoma
- Keywords
- Head and neck cancer, Adaptive radiotherapy, Online adaptive radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Apr 2026 (actual)
- 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.
Radiotherapy of head-neck cancer is associated with significant side effects. Using daily online adaptive radiotherapy to account for the changing anatomy, radiation to organs at risk can be lowered. We will investigate whether this is feasible and associated with a reduction in the risk of toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily online adaptive radiotherapy for head and neck cancer | Experimental | Radiation: Daily online adaptive radiotherapyPatients will undergo daily online adaptive radiotherapy for all fractions in the treatment course. The treatment plan will be re-optimised following recontouring on a daily basis using the Siemens-Varian Ethos Platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer Informed consent as required by law The patient cannot participate in conflicting protocols Stage I-IV (excluding T1-T2N0 carcinoma of the glottic larynx) ECOG/WHO performance status 0-2
Key exclusion criteria (3 listed)
- Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area and unknown primary tumor.
- Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic Distant metastasis Previous radiotherapy of the head and neck Previous surgery for the primary cancer with curative intent
- -
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 |
|---|---|---|
| Daily online adaptive radiotherapyThe patients will undergo daily online adaptive re-optimisation of the radiotherapy treatment plan following daily recontouring. | Radiation | Daily online adaptive radiotherapy for head and neck cancer |
Primary outcome
Risk of dysphagia and xerostomia six months post-treatment assesed by normal-tissue complication probability (NTCP) models
Time frame: 6 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. Not allowed
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily online adaptive radiotherapy in people with Head & Neck Squamous Cell Carcinoma, run by Copenhagen University Hospital, Rigshospitalet 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 1 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: looking for participants now, as of the sponsor's last update on 2 Apr 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeppe Friborg, MD, PhD (+45 35458189, jeppe.friborg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of dysphagia and xerostomia six months post-treatment assesed by normal-tissue complication probability (NTCP) models (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.