REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Head & Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Some patients with head and neck cancer may develop a tumor recurrence in an area that has already been treated with radiotherapy. In these situations, surgery is not always possible, and giving radiotherapy again can be challenging because nearby healthy tissues and organs may already have received high radiation doses. The REPROton-HN study is evaluating the use of proton therapy for these patients. Proton therapy is a type of radiation treatment that can deliver radiation more precisely to the tumor while reducing exposure to surrounding healthy tissues. The aim of the study is to better understand how safe and effective proton therapy is when used as a second course of radiation treatment. Researchers will monitor side effects, tumor control, survival, and patients' quality of life. The results may help improve treatment planning and identify which patients are most likely to benefit from proton therapy in the future.
Primary outcome measures
- Evaluation of toxicities profiles [Time frame: from enrollment to 5 years follow up]
- Number of partecipants with disease free survival [Time frame: from enrollment to 5 years follow up]
- number of patients with Loco-regional control [Time frame: from enrollment to 5 years follow up]
- number of patient with distant metastasis free survival [Time frame: from enrollment to 5 years follow up]
- Quality of life outcomes [Time frame: from enrollment to 5 years follow up]
- assessment of treatment response [Time frame: from enrollment to 5 years follow up]
Eligibility criteria
Inclusion criteria
- ≥ 18 years old
- ECOG 0-2
- Pathologically and or radiologically confirmed head and neck cancer recurrence
- Indication for proton therapy
- Written informed consent for REPRO-HN according to applicable legal and ethical requirements by the end of radiotherapy treatment
Exclusion criteria
- Age < 18 years old
- ECOG>3
- Life expectancy < 3 months
- Inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Humanitas Research Hospital — Rozzano
Identifiers
NCT: NCT07635641 · PRO/OSS - 003/2026