Longitudinal Registry Including Patients Treated With Heavy Particles

Официальное название

CNAO REgistry triAL - REGAL

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия 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.

Первичные конечные точки

• Real world data collection [Срок оценки: 50 years]

Вторичные конечные точки (6)

• Disease evolution [Срок оценки: 50 years]
• Predicitive models [Срок оценки: 50 years]
• Outcome data [Срок оценки: 50 years]
• Toxicities [Срок оценки: 50 years]
• QoL [Срок оценки: 50 years]
• Future research [Срок оценки: 50 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• National Center for Oncological Hadrontherapy (CNAO) — Pavia

Публикации

• Tinganelli W, Durante M. Carbon Ion Radiobiology. Cancers (Basel). 2020 Oct 17;12(10):3022. doi: 10.3390/cancers12103022. PMID 33080914
• 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
• Kraft G. The radiobiological and physical basis for radiotherapy with protons and heavier ions. Strahlenther Onkol. 1990 Jan;166(1):10-3. PMID 2154042
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT05203250 · CNAO OSS 25 2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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