Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Head & Neck Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorIstituto Clinico Humanitas
Academic / other
Drugs / interventionsradiation
Locations1 site (Rozzano, Milano)
StatusRecruiting
StartedMay 29, 2026
Main results expectedJune 2031
Study endsMay 2036
Registry record updatedJune 9, 2026
Trial IDNCT07635641 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.