Proton Re-irradiation for Head and Neck Cancer Recurrence
Official title: REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors
Run by Istituto Clinico Humanitas · NCT07635641 · Data updated 2026-11-12
This study tests whether proton therapy as a second round of radiation is safe and helpful for adults with head and neck cancer that has come back after prior treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rozzano, Milano) |
| Status | Recruiting |
| Started | May 29, 2026 |
| Main results expected | June 2031 |
| Study ends | May 2036 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07635641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with recurrent head and neck cancer who are planned for proton therapy and have ECOG 0-2.
✕Probably not a fit
Patients with very limited life expectancy, poor performance status (ECOG >2), or those unable to receive or tolerate proton therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study follows adults with recurrent head and neck cancer who are slated to receive proton therapy as a second course of radiation. Researchers will monitor safety, tumor control, survival, and quality of life to understand how well proton therapy works in re-irradiation scenarios. The study aims to identify which patients may benefit most and how treatment planning can be optimized to minimize harm to surrounding tissues. No experimental treatments are given; the study observes outcomes from standard clinical care. Participation requires informed consent and is conducted at a single center in Italy.
Why it matters
Potential benefit: If successful, the study could clarify when proton therapy is advantageous for re-irradiation and guide future treatment decisions to improve outcomes.
How similar studies have gone: Previous research in re-irradiation with proton therapy suggests potential for reduced side effects and better targeting, but evidence remains limited and ongoing.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
IRCCS Humanitas Research Hospital
Rozzano, Milano, Italy Recruiting
Study contacts
- Principal investigator: Maria Ausilia Teriaca, MD, radiation oncologist — Humanitas Research Hospital IRCCS, Rozzano-Milan
- Study coordinator: Maria Ausilia Teriaca, MD, radiation oncologist
- Email: maria.ausilia.teriaca@cancercenter.humanitas.it
- Phone: +39 0282247461
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.