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Recruiting NCT07506902

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

No phase Interventional Head & Neck Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Daily online adaptive radiotherapy.
Who it may be relevant to
Registry conditions: Head & Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Risk of dysphagia and xerostomia six months post-treatment assesed by normal-tissue complication probability (NTCP) models [Time frame: 6 months after treatment]

Eligibility 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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07506902 · 2202672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗