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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Re-irradiation with proton | treatment of recurrence of tumor with protontherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | from enrollment to 5 years follow up |
| 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) | from enrollment to 5 years follow up |
| 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) | from enrollment to 5 years follow up |
| 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) | from enrollment to 5 years follow up |
| Quality of life outcomes | evaluation of quality of life of patients through the completion of questionnarie QLQ-C30. Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life) | from enrollment to 5 years follow up |
| assessment of treatment response | assessment of the pathology's response to treatment by imaging | from enrollment to 5 years follow up |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with head and neck cancer who develop locoregional recurrence after prior radiotherapy and candidate to re-irradiation with proton therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Ausilia Teriaca, MD, radiation oncologist | Contact | +39 0282247461 | maria.ausilia.teriaca@cancercenter.humanitas.it | |
| Laura Bonavita, Master degree | Contact | +39 0282247026 | laura.bonavita@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Ausilia Teriaca, MD, radiation oncologist | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | Milano | 20089 | Italy |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
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