Longitudinal Registry Including Patients Treated With Heavy Particles

CNAO National Center of Oncological Hadrontherapy

Status: Enrolling

Conditions: Radiotherapy Side Effect; Oncology; Radiation Toxicity; Cancer; Radiation Exposure; Rare Disease

Treatments: Radiation: Heavy-ion therapy (hadrontherapy)

Study type: Observational

Funder types: Other

Identifiers

NCT05203250

CNAO OSS 25 2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 8 patient groups

Brain tumors, skull base tumors, spinal cord tumors

Description:

NEUROPARTICLE

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Ocular melanomas

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Head and Neck tumors

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Tumors of thorax and/or abdomen

Description:

GI-Particle

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Pelvic tumors

Description:

GYN-Particle

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Sarcomas and tumors of limbs

Description:

SarTAP-Particle

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Pediatric tumors

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)

Mobile spine and sacral tumors

Treatment:

Radiation: Heavy-ion therapy (hadrontherapy)