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.
≥ 18 years old
ECOG 0-2
Pathologically and or radiologically confirmed head and neck cancer recurrence
Indication for proton therapy
Age < 18 years old
ECOG>3
Life expectancy < 3 months
Inability to provide informed consent
All patients with head and neck cancer who develop locoregional recurrence after prior radiotherapy and candidate to re-irradiation with proton therapy
Cohort
Prospective
Not listed
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
Number of partecipants with disease free survival
assessment of the number of patients with no disease progression at follow-ups. Assessed by conventional imaging (PET, RMI, CT)
number of patients with Loco-regional control
assessment of the number of patients with no loco-regional disease progression at follow-ups. Assessed by conventional imaging (PET, RMI, CT)
number of patient with distant metastasis free survival
Assessment of the number of patients with no distant metastasis at follow-ups. Assessed by conventional imaging (PET, RMI, CT)
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