CancerNCT05203250
Longitudinal Registry Including Patients Treated With Heavy Particles
An observational study of Cancer and Oncology, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Oncology, Radiation Exposure
- What is being tested?
- Heavy-ion therapy (hadrontherapy)
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2021to 4 Jun 2071
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated with particle therapy, protons and/or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO), based in Pavia, who have signed the written informed consent document, can be enrolled in the study
Who may be able to join
- 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
Who cannot join
- Patients or legal guardians who are unable to understand informed consent document
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
National Center for Oncological Hadrontherapy (CNAO)
Pavia, 27100
Chiara Campo, PhD, +39 0382-078 407, campo@cnao.it
Cristina Bono, +39 0382078613, bono@cnao.it
About this study
Official title: CNAO REgistry triAL - REGAL
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.
Read the 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.
- Conditions
- Cancer, Oncology, Radiation Exposure, Radiotherapy Side Effect, Radiation Toxicity, Rare Disease
- Being tested
- Heavy-ion therapy (hadrontherapy)
- Keywords
- Hadrontherapy, Oncology, Cancer, Radiotherapy, Protons, Carbon Ions, Heavy ions, Rare cancer
- Medical subject headings
- Neoplasms, Radiation Injuries, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain tumors, skull base tumors, spinal cord tumors | NEUROPARTICLE Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Ocular melanomas | Not described Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Head and Neck tumors | Not described Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Tumors of thorax and/or abdomen | GI-Particle Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Pelvic tumors | GYN-Particle Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Sarcomas and tumors of limbs | SarTAP-Particle Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Pediatric tumors | Not described Receives: Radiation: Heavy-ion therapy (hadrontherapy) | |
| Mobile spine and sacral tumors | Not described Receives: Radiation: Heavy-ion therapy (hadrontherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 50 years
Secondary outcomes (6)
Disease evolution
To analyze the disease course and treatment performed by collecting demographic, disease characteristics and delivered treatment
Measured: 50 years
Predicitive models
To collect details about the radiation treatment and radiobiological parameters to develop predictive models (outcome and toxicity)
Measured: 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
Measured: 50 years
Toxicities
To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment
Measured: 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
Measured: 50 years
Future research
To generate hypotheses for further research
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start4 Jun 2021
- Primary completion4 Jun 2030 (estimated)
- Study completion4 Jun 2071 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203250
- Sponsor's protocol ID
- CNAO OSS 25 2021
- Status last verified
- Aug 2025
- First submitted
- 10 Jan 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tinganelli W, Durante M. Carbon Ion Radiobiology. Cancers (Basel). 2020 Oct 17;12(10):3022. doi: 10.3390/cancers12103022.
PubMed 33080914Durante M, Paganetti H. Nuclear physics in particle therapy: a review. Rep Prog Phys. 2016 Sep;79(9):096702. doi: 10.1088/0034-4885/79/9/096702. Epub 2016 Aug 19.
PubMed 27540827Kraft G. The radiobiological and physical basis for radiotherapy with protons and heavier ions. Strahlenther Onkol. 1990 Jan;166(1):10-3.
PubMed 2154042Weber KJ, Flentje M. Lethality of heavy ion-induced DNA double-strand breaks in mammalian cells. Int J Radiat Biol. 1993 Aug;64(2):169-78. doi: 10.1080/09553009314551261.
PubMed 8103540Mizoe JE, Hasegawa A, Jingu K, Takagi R, Bessyo H, Morikawa T, Tonoki M, Tsuji H, Kamada T, Tsujii H, Okamoto Y; Organizing Committee for the Working Group for Head Neck Cancer. Results of carbon ion radiotherapy for head and neck cancer. Radiother Oncol. 2012 Apr;103(1):32-7. doi: 10.1016/j.radonc.2011.12.013. Epub 2012 Feb 8.
PubMed 22321201Weber DC, Langendijk JA, Grau C, Thariat J. Proton therapy and the European Particle Therapy Network: The past, present and future. Cancer Radiother. 2020 Oct;24(6-7):687-690. doi: 10.1016/j.canrad.2020.05.002. Epub 2020 Aug 1.
PubMed 32753239Langendijk JA, Orecchia R, Haustermans K, Zips D, Balosso J, Lacombe D, Lievens Y, Weber DC, Grau C, Troost EGC. Prospective data registration and clinical trials for particle therapy in Europe. Radiother Oncol. 2018 Jul;128(1):9-13. doi: 10.1016/j.radonc.2018.06.001. Epub 2018 Jul 7.
PubMed 30056852Grau C, Durante M, Georg D, Langendijk JA, Weber DC. Particle therapy in Europe. Mol Oncol. 2020 Jul;14(7):1492-1499. doi: 10.1002/1878-0261.12677. Epub 2020 Apr 22.
PubMed 32223048
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNAO REgistry triAL - REGAL
- ClinicalTrials.gov ID
- NCT05203250
- Acronym / sponsor ID
- CNAO OSS 25 2021
- Conditions
- Cancer, Oncology, Radiation Exposure, Radiotherapy Side Effect, Radiation Toxicity, Rare Disease
- Keywords
- Hadrontherapy, Oncology, Cancer, Radiotherapy, Protons, Carbon Ions, Heavy ions, Rare cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 4 Jun 2030 (estimated)
- Study completion
- 4 Jun 2071 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 50 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Brain tumors, skull base tumors, spinal cord tumors | – | Radiation: Heavy-ion therapy (hadrontherapy)NEUROPARTICLE |
| Ocular melanomas | – | Radiation: Heavy-ion therapy (hadrontherapy) |
| Head and Neck tumors | – | Radiation: Heavy-ion therapy (hadrontherapy) |
| Tumors of thorax and/or abdomen | – | Radiation: Heavy-ion therapy (hadrontherapy)GI-Particle |
| Pelvic tumors | – | Radiation: Heavy-ion therapy (hadrontherapy)GYN-Particle |
| Sarcomas and tumors of limbs | – | Radiation: Heavy-ion therapy (hadrontherapy)SarTAP-Particle |
| Pediatric tumors | – | Radiation: Heavy-ion therapy (hadrontherapy) |
| Mobile spine and sacral tumors | – | Radiation: Heavy-ion therapy (hadrontherapy) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated with particle therapy, protons and/or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO), based in Pavia, who have signed the written informed consent document, can be enrolled in the study
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients or legal guardians who are unable to understand informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy-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. | Radiation | Brain tumors, skull base tumors, spinal cord tumors, Head and Neck tumors, Mobile spine and sacral tumors, Ocular melanomas, Pediatric tumors, Pelvic tumors, Sarcomas and tumors of limbs, Tumors of thorax and/or abdomen |
Primary outcome
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.
6 secondary outcomes
Disease evolution
Time frame: 50 years
Predicitive models
Time frame: 50 years
Outcome data
Time frame: 50 years
Toxicities
Time frame: 50 years
QoL
Time frame: 50 years
Future research
Time frame: 50 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 33080914Tinganelli W, Durante M. Carbon Ion Radiobiology. Cancers (Basel). 2020 Oct 17;12(10):3022. doi: 10.3390/cancers12103022.
- Background: PubMed 27540827Durante M, Paganetti H. Nuclear physics in particle therapy: a review. Rep Prog Phys. 2016 Sep;79(9):096702. doi: 10.1088/0034-4885/79/9/096702. Epub 2016 Aug 19.
- Background: PubMed 2154042Kraft G. The radiobiological and physical basis for radiotherapy with protons and heavier ions. Strahlenther Onkol. 1990 Jan;166(1):10-3.
- Background: PubMed 8103540Weber KJ, Flentje M. Lethality of heavy ion-induced DNA double-strand breaks in mammalian cells. Int J Radiat Biol. 1993 Aug;64(2):169-78. doi: 10.1080/09553009314551261.
- Background: PubMed 22321201Mizoe JE, Hasegawa A, Jingu K, Takagi R, Bessyo H, Morikawa T, Tonoki M, Tsuji H, Kamada T, Tsujii H, Okamoto Y; Organizing Committee for the Working Group for Head Neck Cancer. Results of carbon ion radiotherapy for head and neck cancer. Radiother Oncol. 2012 Apr;103(1):32-7. doi: 10.1016/j.radonc.2011.12.013. Epub 2012 Feb 8.
- Background: PubMed 32753239Weber DC, Langendijk JA, Grau C, Thariat J. Proton therapy and the European Particle Therapy Network: The past, present and future. Cancer Radiother. 2020 Oct;24(6-7):687-690. doi: 10.1016/j.canrad.2020.05.002. Epub 2020 Aug 1.
- Background: PubMed 30056852Langendijk JA, Orecchia R, Haustermans K, Zips D, Balosso J, Lacombe D, Lievens Y, Weber DC, Grau C, Troost EGC. Prospective data registration and clinical trials for particle therapy in Europe. Radiother Oncol. 2018 Jul;128(1):9-13. doi: 10.1016/j.radonc.2018.06.001. Epub 2018 Jul 7.
- Results publication: PubMed 32223048Grau C, Durante M, Georg D, Langendijk JA, Weber DC. Particle therapy in Europe. Mol Oncol. 2020 Jul;14(7):1492-1499. doi: 10.1002/1878-0261.12677. Epub 2020 Apr 22.
- CNAO websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Oncology, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Campo, PhD (+39 0382078407, campo@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world data collection (time frame: 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203250, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.