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Proton therapy is a cancer treatment, similar to the more commonly used radiation therapy. It uses radiation to destroy cancer cells and helps control the disease in the treated area.
However, when proton therapy is compared with standard radiation therapy, many studies show fewer side effects and better disease control. This is due to the unique physical properties of the particles used in proton therapy.
At present, in Italy, this innovative treatment is available only for selected diseases, as defined by national guidelines. For this reason, it is very important to collect as much data as possible to support the further development of proton therapy and to improve treatment safety and effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proton therapy | all patients treated with proton therapy according to clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| collecting real world data | To collect real-world data on cancer patients treated with protonherapy, to support research and to provide evidence of the role of protontherapy in a multidisciplinary approach. | from enrollment to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| toxicities profiles | Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE) | from enrollment to 10 years |
| identify prognostic biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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patients with indication to proton therapy treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Scorsetti, MD, radiation oncologist | Contact | +39 0282248524 | marta.scorsetti@hunimed.eu | |
| Davide Franceschini, MD, radiation oncologist | Contact | +39 0282247428 | davide.franceschini@cancercenter.humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | Michigan | 20025 | Italy |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Investigate biological and clinical factors that influence treatment response and survival (blood samples and saliva samples for Head&Neck patients)
| from enrollment to 10 years |
| Optimize treatment plannig | Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison) | from enrollment to 10 years |
| Secondary Cancer Risk | Monitoring long term cancer incidence in patients treated with proton therapy, especially in young patients (clinical data comparison - appearance of disease after treatment) | from enrollment to 10 years |
| Asses Outcomes in Rare or Radioresistant Tumors | Collect data on tumor types with limited evidence to determine optimal indications for proton therapy (clinical data comparison) | from enrollment to 10 years |
| Monitor Treatment Adherence and Compliance | Evaluate factors influencing patient adherence to treatment schedules and follow up care | from enrollment to 10 years |
| Analyze Quality of Life Outcomes | Measure patient reported outcomes (PROs) to understand the impact of proton therapy on daily life and well being (QLQ-C30 and different questionnaries according to pathology site) | from enrollment to 10 years |