FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach
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 inves...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-03-01
|
| Series: | Radiation Oncology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13014-024-02419-4 |
| _version_ | 1797259065221447680 |
|---|---|
| author | EC Daugherty Y Zhang Z Xiao AE Mascia M Sertorio J Woo C McCann KJ Russell RA Sharma D Khuntia JD Bradley CB Simone JC Breneman JP Perentesis |
| author_facet | EC Daugherty Y Zhang Z Xiao AE Mascia M Sertorio J Woo C McCann KJ Russell RA Sharma D Khuntia JD Bradley CB Simone JC Breneman JP Perentesis |
| author_sort | EC Daugherty |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T23:03:30Z |
| format | Article |
| id | doaj.art-3730163268f8475da81223dd3a8d96e9 |
| institution | Directory Open Access Journal |
| issn | 1748-717X |
| language | English |
| last_indexed | 2024-04-24T23:03:30Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Radiation Oncology |
| spelling | doaj.art-3730163268f8475da81223dd3a8d96e92024-03-17T12:34:00ZengBMCRadiation Oncology1748-717X2024-03-011911910.1186/s13014-024-02419-4FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approachEC Daugherty0Y Zhang1Z Xiao2AE Mascia3M Sertorio4J Woo5C McCann6KJ Russell7RA Sharma8D Khuntia9JD Bradley10CB Simone11JC Breneman12JP Perentesis13Department of Radiation Oncology, University of CincinnatiDepartment of Radiation Oncology, University of CincinnatiDepartment of Radiation Oncology, University of CincinnatiDepartment of Radiation Oncology, University of CincinnatiDepartment of Radiation Oncology, University of CincinnatiVarian, a Siemens Healthineers CompanyVarian, a Siemens Healthineers CompanyVarian, a Siemens Healthineers CompanyVarian, a Siemens Healthineers CompanyVarian, a Siemens Healthineers CompanyDepartment of Radiation Oncology, University of Pennsylvania Department of Radiation Oncology, New York Proton Center Department of Radiation Oncology, University of Cincinnati Cancer and Blood Disease Institute , Cincinnati Children’s Hospital 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.https://doi.org/10.1186/s13014-024-02419-4FLASH radiotherapyProton therapyThoracic bone metastasesFLASH workflowSafetyEfficacy |
| spellingShingle | EC Daugherty Y Zhang Z Xiao AE Mascia M Sertorio J Woo C McCann KJ Russell RA Sharma D Khuntia JD Bradley CB Simone JC Breneman JP Perentesis FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach Radiation Oncology FLASH radiotherapy Proton therapy Thoracic bone metastases FLASH workflow Safety Efficacy |
| title | FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach |
| title_full | FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach |
| title_fullStr | FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach |
| title_full_unstemmed | FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach |
| title_short | FLASH radiotherapy for the treatment of symptomatic bone metastases in the thorax (FAST-02): protocol for a prospective study of a novel radiotherapy approach |
| title_sort | flash radiotherapy for the treatment of symptomatic bone metastases in the thorax fast 02 protocol for a prospective study of a novel radiotherapy approach |
| topic | FLASH radiotherapy Proton therapy Thoracic bone metastases FLASH workflow Safety Efficacy |
| url | https://doi.org/10.1186/s13014-024-02419-4 |
| work_keys_str_mv | AT ecdaugherty flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT yzhang flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT zxiao flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT aemascia flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT msertorio flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT jwoo flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT cmccann flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT kjrussell flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT rasharma flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT dkhuntia flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT jdbradley flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT cbsimone flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT jcbreneman flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach AT jpperentesis flashradiotherapyforthetreatmentofsymptomaticbonemetastasesinthethoraxfast02protocolforaprospectivestudyofanovelradiotherapyapproach |