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

Danish Head and Neck Cancer Group600 enrolled

Overview

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)

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Head-and-neck Cancer

Interventions

Proton radiotherapyRADIATION

Proton radiotherapy

Photon radiotherapyRADIATION

Photon radiotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent * A predicted clinical significant reduction in the risk of any of the two primary endpoints (\>= grade 2 observer-rated dysphagia or grade 4 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans * No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer * Informed consent as required by law * Above 18 years of age Exclusion Criteria: * Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, unknown primary tumor and prior malignancies. * Patients with contraindications for proton therapy. Per October 2020, this includes pacemakers, implanted defibrillators and tracheostomy * 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

Locations (7)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Danish Center for Particle Therapy

Aarhus, Denmark

Outcomes

Primary Outcomes

Dysphagia >= grade 2

The rate of observer-reported dysphagia \>= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best)

Time frame: Six months after end of radiotherapy

Xerostomia = grade 4

The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)

Time frame: Six months after end of radiotherapy

Secondary Outcomes

Loco-regional tumor control

Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure. Rates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint.

Time frame: Up to five years after end of radiotherapy

Overall survival

From date of randomisation to date of death

Time frame: Up to five years after end of radiotherapy

Number of participants with disease-free survival

From date of randomization to date of death (all causes), loco-regional failure or distant failure, whichever comes first

Time frame: Up to five years after end of radiotherapy

Disease-specific survival

From date of randomization to date of death (by loco-regional or distant failure)

Time frame: Up to five years after end of radiotherapy

Acute toxicity

DAHANCA acute toxicity score (grade 0-4, 0 being best)

Central Contacts

Jeppe Friborg, MD, PhD

CONTACT

+45 35458189 jeppe.friborg@regionh.dk

Kenneth Jensen, MD, PhD

CONTACT

+45 78456400 kennjens@rm.dk

Data from ClinicalTrials.gov

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