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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2026-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04607694

Head-and-neck Cancer

UNKNOWN NA

DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

NCT00496652

Cancer of the Head and Neck

COMPLETED PHASE3

Patient-Reported Outcomes in Head and Neck Cancer

NCT03918382

Head and Neck Cancer Radiotherapy Side Effect

UNKNOWN NA

DAHANCA 37. Re-irradiation With Proton Radiotherapy

NCT03981068

Head and Neck Neoplasms

UNKNOWN NA

DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole

NCT01733823

HNSCC,Larynx, Pharynx and Oral Cavity

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Head-and-neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group feasibility study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Proton radiotherapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No