HUmanitas PROtontherapy (HU-PRO)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years old
ECOG (performance status scale) >3
Life expectancy < 3 months
Inability to provide informed consent
Trial population
patients with indication to proton therapy treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: proton therapy
Trial outcomes
Primary outcomes
1
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.
Time frame
from enrollment to 10 yearsSecondary outcomes
1
toxicities profiles
Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE)
Time frame
from enrollment to 10 years2
identify prognostic biomarkers
Investigate biological and clinical factors that influence treatment response and survival (blood samples and saliva samples for Head\&Neck patients)
Time frame
from enrollment to 10 years3
Optimize treatment plannig
Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison)
Time frame
from enrollment to 10 years4
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)
Time frame
from enrollment to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov