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NCT Number: NCT05203250

Longitudinal Registry Including Patients Treated With Heavy Particles

The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.

By keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.

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Key information

Conditions

Cancer Disease Attributes Neoplasms Oncology Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Exposure Radiation Injuries Radiation Toxicity Radiotherapy Side Effect Rare Disease Rare Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Hadrontherapy is a unique radiotherapy (RT) that uses positively charged particles, namely protons and carbons, rather than photons used in conventional RT, to treat cancer.

Particle therapy represents a coming together of physics research applied to oncology and it is currently the most advanced form of radiotherapy for the treatment of tumors that are particularly radio resistant or located nearby sensitive structures.The strength of hadrontherapy lies in the unique physical and radiobiological properties of these particles. Indeed, protons and carbon ions have several biological advantages compared to conventional photon radiotherapy.

In this scenario we aim at constructing a patient registry to retrospectively and prospectively collect real-world data on all cancer patients treated at CNAO, either with protons or carbon ion radiation, independently of their disease (multiple cohorts will be included) for which they were treated.

We aim at collecting data on the natural history of the disease (how the disease presents, develops and progress, its association with other conditions). Those data will allow us to assess prognostic and predictive factors to evaluate treatment effects and toxicities and to provide evidence of the role of radiation oncology in a multidisciplinary approach.

Such registry will be used to generate clinical evidence and high-quality data that could better define the indications for heavy particles therapy and become a resource for the wider scientific community.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients treated with heavy particles at Fondazione CNAO, Pavia
  • Patients who have the ability to understand and be willing to sign a written informed consent document

Exclusion criteria

  • Patients or legal guardians who are unable to understand informed consent document

Treatment and study plan

Heavy-ion therapy (hadrontherapy)

Radiation

Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.

Primary outcomes

  1. Real world data collection

    Time frame: 50 years

    To collect real world data of patients treated with radiotherapy, to support particle radiotherapy and to provide evidence of the role of radiation oncology within the multidisciplinary approach.

Secondary outcomes

  1. Disease evolution

    Time frame: 50 years

    To analyze the disease course and treatment performed by collecting demographic, disease characteristics and delivered treatment

  2. Predicitive models

    Time frame: 50 years

    To collect details about the radiation treatment and radiobiological parameters to develop predictive models (outcome and toxicity)

  3. Outcome data

    Time frame: 50 years

    To collect outcome data (in terms of overall survival, progression free-survival and local control) and to correlate them with the delivered treatment

  4. Toxicities

    Time frame: 50 years

    To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment

  5. QoL

    Time frame: 50 years

    To collect data on standardized QoL questionnaires and PROMS (e,g EORTC C30, EQDL) at 6, 12. 18, 24, 36 months and to correlate them with the delivered treatment

  6. Future research

    Time frame: 50 years

    To generate hypotheses for further research

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Campo, PhD

CONTACT

[email protected]

+39 0382078407

Cristina Bono

CONTACT

[email protected]

+39 0382078613

Sponsors and collaborators

Lead sponsor

CNAO National Center of Oncological Hadrontherapy

Other

Registry information

Official study title

CNAO REgistry triAL - REGAL

Important dates

Study start
2021
Primary completion
2030
Study completion
2071
First posted
Jan 24, 2022
Registry last updated
Aug 6, 2025

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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