REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors

Recruiting now

Conditions studied: Head & Neck Cancer

In brief

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.

Key facts

Study ID

NCT07635641

Run by

Istituto Clinico Humanitas

People needed

50

Starts

2026-05-29

Expected to finish

2036-05-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• Age < 18 years old
• ECOG>3
• Life expectancy < 3 months
• Inability to provide informed consent

Where it is running

• IRCCS Humanitas Research Hospital — Rozzano, Milano, Italy (enrolling)

Full record on ClinicalTrials.gov

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