New radiation therapy approach for head and neck cancer
HYpofractionated, Dose-redistributed RAdiotherapy With Protons and Photons to Combat Radiation-induced Immunosuppression in Head and Neck Squamous Cell Carcinoma (HYDRA)
This study is testing a new way of giving radiation therapy for advanced head and neck cancer to see if it can improve treatment results while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | immunotherapy, radiation, cetuximab, chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05364411 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel hypofractionated radiotherapy technique called HYDRA, which aims to improve outcomes for patients with advanced head and neck squamous cell carcinoma (HNSCC). The approach involves delivering a higher dose of radiation in fewer sessions while minimizing damage to the immune system. Patients will receive targeted radiation doses based on their tumor characteristics, potentially combined with standard radiosensitizers like cisplatin or cetuximab. The goal is to enhance the effectiveness of treatment while reducing the adverse effects typically associated with conventional radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with squamous cell carcinoma of the oropharynx, hypopharynx, or larynx who are eligible for curative intent proton or photon therapy.
Not a fit: Patients with non-squamous cell carcinomas or those not suitable for curative intent radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced HNSCC.
How similar studies have performed: While the approach is innovative, previous studies have shown mixed results with similar combinations of radiotherapy and immunotherapy, indicating the need for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: * ≥ 18 years old at time of signing informed consent. * WHO 0-2 * Squamous cell carcinoma of the oropharynx, hypopharynx and larynx\* proven by cytology / histology * Patients amenable for curative intent proton therapy (by model-based selection criteria, according to the Dutch standard of care) or photon therapy. * Radiotherapy with or without concurrent radiosensitizer. * Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician. * Written informed consent obtained. * Note: The HYDRA dose prescriptions should be applicable for all HNSCC patients and should therefore ideally be tested within the full range of treatment indications, e.g. multiple tumor subsites and both chemoradiotherapy and radiotherapy alone. There are several reports about acceptable acute toxicity following hypofractionated chemoradiotherapy in advanced stage HNSCC. However, concerns about late toxicity remain, especially for laryngeal carcinoma. Patients with laryngeal carcinoma are therefore initially excluded, until these patients are also considered eligible for treatment with HYDRA. The statistical considerations and interim safety analyses for this purpose and the decision-making / consultation are further described elsewhere. Exclusion criteria Patients who do not meet the inclusion criteria as specified in paragraph 4.2, and/or who meet the following additional criteria: * Previously treated by irradiation on the same target volume * Chronic inflammatory disease or immune disorders which, according to the principal investigator, may disturb the translational immune-read out. * Patients currently under treatment for other malignant disease (unless in situ carcinoma or basal cell carcinoma of the skin), or treated for other malignant disease within the last 2 years. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule in the participating hospitals. * Any other serious medical condition that could interfere with follow-up.
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joris BW Elbers, MD, PhD — Erasmus MC, Rotterdam / HollandPTC, Delft - The Netherlands
- Study coordinator: Joris BW Elbers, MD, PhD
- Email: j.elbers@erasmusmc.nl
- Phone: 0031207041249
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.