FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach.

Autor: Daugherty EC; Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA., Zhang Y; Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.; Cancer and Blood Disease Institute , Cincinnati Children's Hospital , Cincinnati, OH, USA., Xiao Z; Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.; Cancer and Blood Disease Institute , Cincinnati Children's Hospital , Cincinnati, OH, USA., Mascia AE; Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA.; Cancer and Blood Disease Institute , Cincinnati Children's Hospital , Cincinnati, OH, USA., Sertorio M; Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA., Woo J; Varian, a Siemens Healthineers Company, Palo Alto, USA., McCann C; Varian, a Siemens Healthineers Company, Palo Alto, USA., Russell KJ; Varian, a Siemens Healthineers Company, Palo Alto, USA., Sharma RA; Varian, a Siemens Healthineers Company, Palo Alto, USA., Khuntia D; Varian, a Siemens Healthineers Company, Palo Alto, USA., Bradley JD; Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA., Simone CB 2nd; Department of Radiation Oncology, New York Proton Center , New York, NY, USA., Breneman JC; Department of Radiation Oncology, University of Cincinnati, Cincinnati, OH, USA., Perentesis JP; Cancer and Blood Disease Institute , Cincinnati Children's Hospital , Cincinnati, OH, USA. john.perentesis@cchmc.org.
Jazyk: angličtina
Zdroj: Radiation oncology (London, England) [Radiat Oncol] 2024 Mar 12; Vol. 19 (1), pp. 34. Date of Electronic Publication: 2024 Mar 12.
DOI: 10.1186/s13014-024-02419-4
Abstrakt: Background: FLASH therapy is a treatment technique in which radiation is delivered at ultra-high dose rates (≥ 40 Gy/s). The first-in-human FAST-01 clinical trial demonstrated the clinical feasibility of proton FLASH in the treatment of extremity bone metastases. The objectives of this investigation are to assess the toxicities of treatment and pain relief in study participants with painful thoracic bone metastases treated with FLASH radiotherapy, as well as workflow metrics in a clinical setting.
Methods: This single-arm clinical trial is being conducted under an FDA investigational device exemption (IDE) approved for 10 patients with 1-3 painful bone metastases in the thorax, excluding bone metastases in the spine. Treatment will be 8 Gy in a single fraction administered at ≥ 40 Gy/s on a FLASH-enabled proton therapy system delivering a single transmission proton beam. Primary study endpoints are efficacy (pain relief) and safety. Patient questionnaires evaluating pain flare at the treatment site will be completed for 10 consecutive days post-RT. Pain response and adverse events (AEs) will be evaluated on the day of treatment and on day 7, day 15, months 1, 2, 3, 6, 9, and 12, and every 6 months thereafter. The outcomes for clinical workflow feasibility are the occurrence of any device issues as well as time on the treatment table.
Discussion: This prospective clinical trial will provide clinical data for evaluating the efficacy and safety of proton FLASH for palliation of bony metastases in the thorax. Positive findings will support the further exploration of FLASH radiation for other clinical indications including patient populations treated with curative intent.
Registration: ClinicalTrials.gov NCT05524064.
(© 2024. The Author(s).)
Databáze: MEDLINE
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