Longitudinal Registry Including Patients Treated With Heavy Particles

Cancer Clinical Trial

Official title:

CNAO REgistry triAL - REGAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203250
• Other study ID #: CNAO OSS 25 2021
• Status: Recruiting
• Start date: June 4, 2021
• Est. completion date: June 4, 2071

Study information

• Verified date: January 2024
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: Chiara Campo, PhD
• Phone: +39 0382078407
• Email: campo[@]cnao.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 4, 2071
• Est. primary completion date: June 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Oncology
• Radiation Exposure
• Radiation Toxicity
• Radiotherapy Side Effect
• Rare Disease
• Rare Diseases

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Italy	National Center for Oncological Hadrontherapy (CNAO)	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Durante 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. — View Citation

Grau 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. — View Citation

Kraft G. The radiobiological and physical basis for radiotherapy with protons and heavier ions. Strahlenther Onkol. 1990 Jan;166(1):10-3. — View Citation

Langendijk 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. — View Citation

Mizoe 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. — View Citation

Tinganelli W, Durante M. Carbon Ion Radiobiology. Cancers (Basel). 2020 Oct 17;12(10):3022. doi: 10.3390/cancers12103022. — View Citation

Weber 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. — View Citation

Weber 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. — View Citation

Outcome

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

External Links

•   CNAO website