Status:
ACTIVE_NOT_RECRUITING
Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
Lead Sponsor:
Danish Head and Neck Cancer Group
Conditions:
Head-and-neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 dy...
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 loca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05423704
Start Date
May 20 2019
End Date
May 14 2026
Last Update
June 21 2022
Active Locations (7)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark
3
Danish Center for Particle Therapy
Aarhus, Denmark
4
Rigshospitalet
Copenhagen, Denmark