Clinical trial NCT05423704: Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
Official title: DAHANCA Proton Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head-and-neck Cancer
Keywords: Proton radiotherapy
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
First posted: 2022-06-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group feasibility study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 2 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, nasopharynx, unknown primary tumor and prior malignancies.

Patients with contraindications for proton therapy (as per 2019 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

Primary outcomes:
measure: Dysphagia >= grade 2
timeFrame: Six months after end of radiotherapy
measure: Xerostomia = grade 2
timeFrame: Six months after end of radiotherapy
Secondary outcomes:
measure: Loco-regional tumor control
timeFrame: Up to five years after end of radiotherapy
measure: Overall survival
timeFrame: Up to five years after end of radiotherapy]
measure: Acute toxicity
timeFrame: From the beginning of and up to two months after end of radiotherapy]
measure: Late toxicity
timeFrame: From two months to five years after end of radiotherapy]
measure: EORTC QLQ-Head-Neck 35
timeFrame: Up to five years after end of radiotherapy
measure: EORTC C30
timeFrame: Up to five years after end of radiotherapy]
measure: Time from referral to treatment
timeFrame: From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Danish Center for Particle Therapy
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Næstved
country: Denmark
facility: Næstved Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Danish Head-Neck Cancer Group (DAHANCA)
name: Jeppe Friborg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: