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

NCT07506902 | Recruiting

• 1 other identifier: 2202672
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head & Neck Squamous Cell Carcinoma

Keywords

Head and neck cancer; Adaptive radiotherapy; Online adaptive radiotherapy

Outcome Measures

Primary Outcomes (1)

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

  6 months after treatment

Study Arms (1)

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.

Radiation: Daily online adaptive radiotherapy

Interventions

Daily online adaptive radiotherapy RADIATION

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

Daily online adaptive radiotherapy for head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Central Study Contacts

Jeppe Friborg, MD, PhD

CONTACT

+45 35458189; jeppe.friborg@regionh.dk

Anne Lindegaard, MD

CONTACT

+45 35456107; anne.marie.mira.lindegaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: November 21, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)