Longitudinal Registry Including Patients Treated with Heavy Particles

Recruiting

• Conditions: Radiotherapy Side Effect; Radiation Toxicity; Rare Disease; Cancer; Radiation Exposure; Oncology
• Interventions: Radiation: Heavy-ion therapy (hadrontherapy)

• Registration Number: NCT05203250
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-06-04
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-06-04
• Study Completion: 2071-06-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumors of thorax and/or abdomen	Heavy-ion therapy (hadrontherapy)	GI-Particle
Sarcomas and tumors of limbs	Heavy-ion therapy (hadrontherapy)	SarTAP-Particle
Head and Neck tumors	Heavy-ion therapy (hadrontherapy)	-
Mobile spine and sacral tumors	Heavy-ion therapy (hadrontherapy)	-
Brain tumors, skull base tumors, spinal cord tumors	Heavy-ion therapy (hadrontherapy)	NEUROPARTICLE
Ocular melanomas	Heavy-ion therapy (hadrontherapy)	-
Pelvic tumors	Heavy-ion therapy (hadrontherapy)	GYN-Particle
Pediatric tumors	Heavy-ion therapy (hadrontherapy)	-

Primary Outcome Measures

Name	Time	Method
Real world data collection	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 Outcome Measures

Name	Time	Method
Predicitive models	50 years	To collect details about the radiation treatment and radiobiological parameters to develop predictive models (outcome and toxicity)
Outcome data	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
QoL	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
Toxicities	50 years	To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment
Disease evolution	50 years	To analyze the disease course and treatment performed by collecting demographic, disease characteristics and delivered treatment
Future research	50 years	To generate hypotheses for further research

Trial Locations

Locations (1)

National Center for Oncological Hadrontherapy (CNAO); 🇮🇹 Pavia, Italy