Adaptive daily replanning of radiotherapy for head and neck cancer.
Official title: DART-HN - Daily Adaptive Radiotherapy of Head-neck Cancer.
Run by Copenhagen University Hospital, Rigshospitalet · NCT07506902 · Data updated 2026-11-12
This tests whether doing same-day replanning of radiotherapy each treatment can reduce side effects for people receiving curative radiotherapy for head and neck squamous cell carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | November 21, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT07506902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary curative radiotherapy, stage I–IV (excluding early glottic T1–T2N0), ECOG 0–2, able to attend daily treatments and follow-up at the study center.
✕Probably not a fit
Patients unlikely to benefit include those with prior head and neck radiotherapy, distant metastases, non-squamous histology, cancers of the skull base/sinonasal area or early glottic tumors, or those unable to attend daily treatment sessions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The intervention uses daily online adaptive radiotherapy with same-day replanning and optimization to account for anatomical changes during a curative course of radiotherapy for pharyngeal or laryngeal squamous cell carcinoma. Imaging is acquired before each fraction and the treatment plan is modified to spare nearby organs at risk when anatomy has shifted. The main goals are to test feasibility of the workflow and to see if daily adaptation lowers radiation dose to healthy tissues and reduces acute and late toxicity. Eligible patients are treated at Rigshospitalet in Copenhagen and include adults with histologically proven pharynx or larynx SCC (stage I–IV excluding T1–T2N0 glottic), ECOG 0–2, without prior head and neck radiotherapy or distant metastases.
Why it matters
Potential benefit: If successful, this approach could lower radiation exposure to healthy tissues and reduce both short- and long-term treatment-related toxicities such as swallowing dysfunction and dry mouth.
How similar studies have gone: Prior dosimetric and small feasibility studies have shown that online adaptive radiotherapy can spare organs at risk, but large randomized evidence demonstrating reduced clinical toxicity remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 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 \-
Where it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Jeppe Friborg, MD, PhD
- Email: jeppe.friborg@regionh.dk
- Phone: +45 35458189
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.