Comparing proton and photon therapy for head and neck cancer
DAHANCA 35: A Randomized Trial of Proton Versus Photon Radiotherapy for the Treatment of Head-neck Cancer
This study is testing whether proton therapy is better than photon therapy for treating head and neck cancer in patients to see if it reduces the risk of swallowing problems and dry mouth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danish Head and Neck Cancer Group Research network |
| Locations | 7 sites (Aalborg and 6 other locations) |
| Trial ID | NCT04607694 on ClinicalTrials.gov |
What this trial studies
DAHANCA 35 is a clinical trial that compares the effectiveness of proton radiotherapy versus photon radiotherapy in patients with squamous cell carcinoma of the pharynx or larynx. Patients are randomized to receive either treatment based on a predicted significant reduction in the risk of late dysphagia or xerostomia. The trial consists of two parallel studies focusing on different primary endpoints related to these side effects. A total of 600 patients will be enrolled to assess the outcomes of each treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed squamous cell carcinoma of the pharynx or larynx who are planned for primary radiotherapy.
Not a fit: Patients with glottic larynx cancers, prior malignancies, or contraindications for proton therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options that minimize debilitating side effects for patients with head and neck cancer.
How similar studies have performed: Previous studies have shown promising results with proton therapy in reducing side effects in cancer treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Aalborg and 6 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Danish Center for Particle Therapy — Aarhus, Denmark (Recruiting)
- Herlev Hospital — Copenhagen, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Næstved Hospital — Næstved, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Jeppe Friborg, MD, PhD — Danish Head-Neck Cancer Group (DAHANCA)
- Study coordinator: Jeppe Friborg, MD, PhD
- Email: jeppe.friborg@regionh.dk
- Phone: +45 35458189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.