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

Istituto Clinico Humanitas50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head & Neck Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Evaluation of toxicities profiles

To Evaluate Short and Long-Term Toxicity Profiles - Assess acute and late-onset side effects and compare toxicity rates with conventional radiotherapy. Adverse event will be evaluated through CTCAE V.5.0 classification