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Spots Global Cancer Trial Database for DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer

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Trial Identification

Brief Title: DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer

Official Title: DAHANCA 35: A Randomized Trial of Proton Versus Photon Radiotherapy for the Treatment of Head-neck Cancer

Study ID: NCT04607694

Study Description

Brief Summary: Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)

Detailed Description: DAHANCA 35 is two parallel conducted, but separate randomized studies, within the same trial (DAHANCA 35D and DAHANCA 35X) by the Danish Head-Neck Cancer Study Group (DAHANCA). In patients with squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy a proton and a photon doseplan is prepared. If proton radiotherapy reduces the anticipated absolute risk of dysphagia \>= grade 2 (DAHANCA scale, DAHANCA 35D) or severe xerostomia \>= grade 4 (EORTC Head-Neck 35, DAHANCA 35X) more than 5%, the patient is randomised to either proton therapy or photon therapy, 2:1. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). Patient are analysed according to the primary endpoint (dysphagia and/or xerostomia) after which they were enrolled. DAHANCA 35D is expected to enroll 360 patients and DAHANCA 35X 240 patients (in total 600 patients).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Aalborg University Hospital, Aalborg, , Denmark

Aarhus University Hospital, Aarhus, , Denmark

Danish Center for Particle Therapy, Aarhus, , Denmark

Herlev Hospital, Copenhagen, , Denmark

Rigshospitalet, Copenhagen, , Denmark

Næstved Hospital, Næstved, , Denmark

Odense University Hospital, Odense, , Denmark

Contact Details

Name: Jeppe Friborg, MD, PhD

Affiliation: Danish Head-Neck Cancer Group (DAHANCA)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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