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. 2024 Mar 12;19(1):34.
doi: 10.1186/s13014-024-02419-4.

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

E C Daugherty  1 , Y Zhang  1   2 , Z Xiao  1   2 , A E Mascia  1   2 , M Sertorio  1 , J Woo  3 , C McCann  3 , K J Russell  3 , R A Sharma  3 , D Khuntia  3 , J D Bradley  4 , C B Simone 2nd  5 , J C Breneman  1 , J P Perentesis  6
Affiliations

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

E C Daugherty et al. Radiat Oncol. .

Abstract

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.

Keywords: Adverse effects; Efficacy; FLASH radiotherapy; FLASH workflow; Pain relief; Proton therapy; Safety; Thoracic bone metastases; Ultra-high dose rate.

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Conflict of interest statement

Dr Mascia reported grants and personal fees from Varian Medical Systems during the conduct of the study. Dr Daugherty reported personal fees from Varian Medical Systems during the conduct of the study. Dr Sertorio reported grants from Varian Medical Systems during the conduct of the study. Ms Woo reported employment at Varian Medical Systems, the commercial sponsor of the study. Dr McCann reported employment at Varian Medical Systems, the commercial sponsor of the study. Dr Russell reported employment at Varian Medical Systems, the commercial sponsor of the study. Dr Sharma reported employment at Varian Medical Systems, the commercial sponsor of the study. Dr Khuntia reported employment at Varian Medical Systems, the commercial sponsor of the study, as well as multiple FLASH patents issued. Dr Bradley reported grants and personal fees from Varian Medical Systems outside the submitted work. Dr Simone reported personal fees from Varian Medical Systems during the conduct of the study. Dr Perentesis reported grants from Varian Medical Systems, Bristol Myers Squibb, Jazz Pharmaceuticals, and Incyte outside the submitted work. Dr Breneman reported funds from Varian Medical Systems to the institute during the conduct of the study and personal fees from Varian Medical Systems. No other disclosures were reported.

The authors declare no competing interests.

References

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