CancerHU-PRONCT07317245
HUmanitas PROtontherapy (HU-PRO)
An observational study of Cancer and Proton Therapy, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Proton Therapy
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2026to Jan 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with indication to proton therapy treatment
Who may be able to join
- 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
Who cannot join
- Age < 18 years old
- ECOG (performance status scale) >3
- Life expectancy < 3 months
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Davide Franceschini, MD, radiation oncologist contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Michigan, 20025
Laura Bonavita, master degree, +390282247026, laura.bonavita@humanitas.it
Barbara Alt, +390282248513, barbara.alt@humanitas.it
About this study
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.
- Conditions
- Cancer, Proton Therapy
- Keywords
- registry, cancer, proton therapy, re-irradiation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| proton therapy | all patients treated with proton therapy according to clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to 10 years
Secondary outcomes (7)
toxicities profiles
Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE)
Measured: from enrollment to 10 years
identify prognostic biomarkers
Investigate biological and clinical factors that influence treatment response and survival (blood samples and saliva samples for Head\&Neck patients)
Measured: from enrollment to 10 years
Optimize treatment plannig
Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison)
Measured: 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)
Measured: 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)
Measured: from enrollment to 10 years
Monitor Treatment Adherence and Compliance
Evaluate factors influencing patient adherence to treatment schedules and follow up care
Measured: 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)
Measured: from enrollment to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start12 Jan 2026
- Primary completionJan 2036 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317245
- Sponsor's protocol ID
- PRO/OSS - 001/2026
- Acronym
- HU-PRO
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUmanitas PROtontherapy (HU-PRO)
- ClinicalTrials.gov ID
- NCT07317245
- Acronym / sponsor ID
- HU-PRO / PRO/OSS - 001/2026
- Conditions
- Cancer, Proton Therapy
- Keywords
- registry, cancer, proton therapy, re-irradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proton therapy | – | –all patients treated with proton therapy according to clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with indication to proton therapy treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age < 18 years old
- ECOG (performance status scale) >3
- Life expectancy < 3 months
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
collecting real world data
Time frame: 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.
7 secondary outcomes
toxicities profiles
Time frame: from enrollment to 10 years
identify prognostic biomarkers
Time frame: from enrollment to 10 years
Optimize treatment plannig
Time frame: from enrollment to 10 years
Secondary Cancer Risk
Time frame: from enrollment to 10 years
Asses Outcomes in Rare or Radioresistant Tumors
Time frame: from enrollment to 10 years
Monitor Treatment Adherence and Compliance
Time frame: from enrollment to 10 years
Analyze Quality of Life Outcomes
Time frame: from enrollment to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide Franceschini, MD, radiation oncologist contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Proton Therapy, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Scorsetti, MD, radiation oncologist (+39 0282248524, marta.scorsetti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collecting real world data (time frame: from enrollment to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.