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REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Rec

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 dose

Condition(s)Head & Neck Cancer
StatusRecruiting
Study typeObservational
SummarySome 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. Th
Who can participateInclusion 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
Ages18 Years
SexAll
Lead sponsorIstituto Clinico Humanitas
LocationsRozzano, Milano, Italy
Start date2026-05-29
NCT IDNCT07635641
Official listinghttps://clinicaltrials.gov/study/NCT07635641

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