Adaptive daily replanning of radiotherapy for head and neck cancer.
DART-HN - Daily Adaptive Radiotherapy of Head-neck Cancer.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07506902 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Jeppe Friborg, MD, PhD
- Email: jeppe.friborg@regionh.dk
- Phone: +45 35458189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.