NCT05423704

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

DAHANCA Proton Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Danish Head and Neck Cancer Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head-and-neck Cancer

Interventions

Type	Name	Description
OTHER	Proton radiotherapy	Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients

Timeline

• Start date: 2019-05-20
• Primary completion: 2021-11-14
• Completion: 2026-05-14
• First posted: 2022-06-21
• Last updated: 2022-06-21

Locations

7 sites across 1 country: Denmark