Longitudinal Registry Including Patients Treated With Heavy Particles

NCT05203250 | Recruiting

• 1 other identifier: CNAO OSS 25 2021
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Oncology; Radiation Exposure; Radiotherapy Side Effect; Radiation Toxicity; Rare Disease

Keywords

Hadrontherapy; Oncology; Cancer; Radiotherapy; Protons; Carbon Ions; Heavy ions; Rare cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Disease evolution

  50 years

• Predicitive models

  50 years

• Outcome data

  50 years

• Toxicities

  50 years

• QoL

  50 years

Study Arms (8)

Brain tumors, skull base tumors, spinal cord tumors

NEUROPARTICLE

Radiation: Heavy-ion therapy (hadrontherapy)

Ocular melanomas

Radiation: Heavy-ion therapy (hadrontherapy)

Head and Neck tumors

Radiation: Heavy-ion therapy (hadrontherapy)

Tumors of thorax and/or abdomen

GI-Particle

Radiation: Heavy-ion therapy (hadrontherapy)

Pelvic tumors

GYN-Particle

Radiation: Heavy-ion therapy (hadrontherapy)

Sarcomas and tumors of limbs

SarTAP-Particle

Radiation: Heavy-ion therapy (hadrontherapy)

Pediatric tumors

Radiation: Heavy-ion therapy (hadrontherapy)

Mobile spine and sacral tumors

Radiation: Heavy-ion therapy (hadrontherapy)

Interventions

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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patients or legal guardians who are unable to understand informed consent document

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

National Center for Oncological Hadrontherapy (CNAO)

Pavia, 27100, Italy

RECRUITING

Related Publications (8)

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

  PMID: 33080914 BACKGROUND

• 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.

  PMID: 27540827 BACKGROUND

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

  PMID: 2154042 BACKGROUND

• 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.

  PMID: 8103540 BACKGROUND

• 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.

  PMID: 22321201 BACKGROUND

• 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.

  PMID: 32753239 BACKGROUND

• 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.

  PMID: 30056852 BACKGROUND

• 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.

  PMID: 32223048 RESULT

Related Links

• CNAO website

MeSH Terms

Conditions

Neoplasms; Radiation Injuries; Rare Diseases

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Central Study Contacts

Chiara Campo, PhD

CONTACT

+39 0382078407; campo@cnao.it

Cristina Bono

CONTACT

+39 0382078613; bono@cnao.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: June 4, 2021
• Primary Completion (Estimated): June 4, 2030
• Study Completion (Estimated): June 4, 2071
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

IT (1)