NCT07635641 REPROton-HN: Prospective Observational Study on Proton Re-irradiation for Locoregional Recurrences of Head and Neck Tumors
| NCT ID | NCT07635641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Head & Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2031-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-05-29 with a primary completion date of 2031-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Maria Ausilia Teriaca, MD, radiation oncologist
✉ maria.ausilia.teriaca@cancercenter.humanitas.it📞 +39 0282247461
Maria Ausilia Teriaca, MD, radiation oncologist
PRINCIPAL INVESTIGATOR
Humanitas Research Hospital IRCCS, Rozzano-Milan
Frequently Asked Questions
Who can join the NCT07635641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head & Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07635641 currently recruiting?
Yes, NCT07635641 is actively recruiting participants. Contact the research team at maria.ausilia.teriaca@cancercenter.humanitas.it for enrollment information.
Where is the NCT07635641 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT07635641 clinical trial?
NCT07635641 is sponsored by Istituto Clinico Humanitas. The principal investigator is Maria Ausilia Teriaca, MD, radiation oncologist at Humanitas Research Hospital IRCCS, Rozzano-Milan. The trial plans to enroll 50 participants.
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