Cancer, Proton Therapy
Conditions
Keywords
registry, cancer, proton therapy, re-irradiation
Brief summary
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.
Interventions
None listed
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid tumors candidate to proton therapy, in particular, according to Italian regolamentations * Written informed consent for HU-PRO according to applicable legal and ethical requirements * Indication for proton therapy * ≥ 18 years old * ECOG PS (performance status scale) 0-2
Exclusion criteria
* Age \< 18 years old * ECOG (performance status scale) \>3 * Life expectancy \< 3 months * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| collecting real world data | from enrollment to 10 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| toxicities profiles | from enrollment to 10 years | Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE) |
| identify prognostic biomarkers | from enrollment to 10 years | Investigate biological and clinical factors that influence treatment response and survival (blood samples and saliva samples for Head\&Neck patients) |
| Optimize treatment plannig | from enrollment to 10 years | Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison) |
| Secondary Cancer Risk | from enrollment to 10 years | Monitoring long term cancer incidence in patients treated with proton therapy, especially in young patients (clinical data comparison - appearance of disease after treatment) |
| Asses Outcomes in Rare or Radioresistant Tumors | from enrollment to 10 years | Collect data on tumor types with limited evidence to determine optimal indications for proton therapy (clinical data comparison) |
| Monitor Treatment Adherence and Compliance | from enrollment to 10 years | Evaluate factors influencing patient adherence to treatment schedules and follow up care |
| Analyze Quality of Life Outcomes | from enrollment to 10 years | 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) |
Countries
Italy
Contacts
CONTACTMarta Scorsetti, MD, radiation oncologist
CONTACTDavide Franceschini, MD, radiation oncologist
Outcome results
None listed