Cancer, Oncology, Radiation Exposure, Radiation Toxicity, Radiotherapy Side Effect, Rare Disease
Conditions
Keywords
Hadrontherapy, Oncology, Cancer, Radiotherapy, Protons, Carbon Ions, Heavy ions, Rare cancer
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.
Interventions
RADIATIONHeavy-ion therapy (hadrontherapy)
Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.
Sponsors
CNAO National Center of Oncological Hadrontherapy
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Disease evolution | 50 years | To analyze the disease course and treatment performed by collecting demographic, disease characteristics and 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 |
| Future research | 50 years | To generate hypotheses for further research |
| Toxicities | 50 years | To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment |
Countries
Italy
Contacts
Primary ContactChiara Campo, PhD
Backup ContactCristina Bono
Outcome results
None listed