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NCT Number: NCT07317245

HUmanitas PROtontherapy (HU-PRO)

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.

Recruiting

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Key information

Conditions

Cancer Neoplasms Proton Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Humanitas Research Hospital

Rozzano, Michigan, 20025, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. toxicities profiles

    Time frame: from enrollment to 10 years

    Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE)

  2. identify prognostic biomarkers

    Time frame: 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)

  3. Optimize treatment plannig

    Time frame: from enrollment to 10 years

    Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison)

  4. Secondary Cancer Risk

    Time frame: 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)

  5. Asses Outcomes in Rare or Radioresistant Tumors

    Time frame: from enrollment to 10 years

    Collect data on tumor types with limited evidence to determine optimal indications for proton therapy (clinical data comparison)

  6. Monitor Treatment Adherence and Compliance

    Time frame: from enrollment to 10 years

    Evaluate factors influencing patient adherence to treatment schedules and follow up care

  7. Analyze Quality of Life Outcomes

    Time frame: 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)

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Acronym: HU-PRO

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Jan 5, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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