Longitudinal Registry Including Patients Treated With Heavy Particles

Study Overview
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Brief Summary
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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
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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.

Official Title
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CNAO REgistry triAL - REGAL

Conditions
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Cancer, Oncology, Radiation Exposure, Radiotherapy Side Effect, Radiation Toxicity, Rare Disease

Intervention / Treatment
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* Radiation: Heavy-ion therapy (hadrontherapy)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brain tumors, skull base tumors, spinal cord tumors<br>NEUROPARTICLE | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Ocular melanomas<br> | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Head and Neck tumors<br> | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Tumors of thorax and/or abdomen<br>GI-Particle | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Pelvic tumors<br>GYN-Particle | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Sarcomas and tumors of limbs<br>SarTAP-Particle | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Pediatric tumors<br> | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|
| Mobile spine and sacral tumors<br> | Radiation: Heavy-ion therapy (hadrontherapy)<br>* Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real world data collection | 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. | 50 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease evolution | To analyze the disease course and treatment performed by collecting demographic, disease characteristics and delivered treatment | 50 years | 
| Predicitive models | To collect details about the radiation treatment and radiobiological parameters to develop predictive models (outcome and toxicity) | 50 years | 
| Outcome data | To collect outcome data (in terms of overall survival, progression free-survival and local control) and to correlate them with the delivered treatment | 50 years | 
| Toxicities | To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment | 50 years | 
| QoL | 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 | 50 years | 
| Future research | To generate hypotheses for further research | 50 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hadrontherapy, Oncology, Cancer, Radiotherapy, Protons, Carbon Ions, Heavy ions, Rare cancer