Spots Global Cancer Trial Database for Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark

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Trial Identification

Brief Title: Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark

Official Title: DAHANCA Proton Feasibility Study

Study ID: NCT05423704

Conditions

Head-and-neck Cancer

Interventions

Proton radiotherapy

Study Description

Brief Summary: A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.

Detailed Description: In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia \>= grade 2 (DAHANCA scale and/or xerostomia \>= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). At least five patients from each of the six Danish centers are required in this feasibility study.