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NCT Number: NCT07506902

A Study of Adaptive Radiotherapy of Head-neck Cancer Using Daily Replanning and Optimization of the Treatment Plan.

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.

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Key information

Conditions

Head & Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Daily online adaptive radiotherapy

Radiation

The patients will undergo daily online adaptive re-optimisation of the radiotherapy treatment plan following daily recontouring.

Primary outcomes

  1. Risk of dysphagia and xerostomia six months post-treatment assesed by normal-tissue complication probability (NTCP) models

    Time frame: 6 months after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Lindegaard, MD

CONTACT

[email protected]

+45 35456107

Jeppe Friborg, MD, PhD

CONTACT

[email protected]

+45 35458189

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

DART-HN - Daily Adaptive Radiotherapy of Head-neck Cancer.

Acronym: DART-HN

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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