{"entity":{"id":"fast-01","kind":"trial","name":"FAST-01 (proton FLASH for bone metastases)","aka":["FAST-01 trial","Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases"],"tldr":"The first clinical trial of ultra-fast proton radiotherapy, in ten patients with painful bone metastases in the limbs. Treatment ran without technical problems and side effects were like those of ordinary radiotherapy.","summary":"FAST-01 treated 10 patients at 12 sites with a single transmission proton beam at 40 Gy per second or more on a FLASH-enabled Varian ProBeam, prescribing 8 Gy as in standard palliative care. There were no FLASH-related technical problems or delays; average time on the couch was 18.9 minutes per patient. Adverse events were mild and consistent with conventional radiotherapy, and transient pain flares occurred. It established workflow feasibility, not a tissue-sparing benefit.","status":"completed","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT04592887","url":"https://clinicaltrials.gov/study/NCT04592887"},{"label":"Mascia et al., proton FLASH for symptomatic bone metastases: the FAST-01 trial (JAMA Oncology 2023)","url":"https://doi.org/10.1001/jamaoncol.2022.5843"}],"tags":["machines-wave3"],"related":[],"cancers":[],"sections":[],"technologies":["flash-rt","flash-research-accelerators","proton-therapy-systems"],"targets":[],"drugs":[],"companies":["varian"],"institutions":[],"pathways":[],"terms":["bone-metastases"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"nct":"NCT04592887","phase":"not-applicable","setting":"Adults with one to three painful bone metastases in the arms or legs, treated with a single 8 Gy proton FLASH fraction at Cincinnati Children's/UC Health Proton Therapy Center","sponsor":"Varian, a Siemens Healthineers Company","result":"Proton FLASH was delivered without technical issues in 10 patients; side effects were mild and similar to conventional radiotherapy.","started":"2020-11-03","startedType":"actual","yearReported":2023,"enrolled":10,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/fast-01/","neighbours":{"technology":[{"id":"flash-rt","kind":"technology","name":"FLASH radiotherapy","route":"/technologies/flash-rt/"},{"id":"flash-research-accelerators","kind":"technology","name":"FLASH research accelerators (Oriatron, Mobetron FLASH, ProBeam FLASH)","route":"/technologies/flash-research-accelerators/"},{"id":"proton-therapy-systems","kind":"technology","name":"Proton therapy machines: cyclotrons, synchrotrons and single-room systems","route":"/technologies/proton-therapy-systems/"}],"company":[{"id":"varian","kind":"company","name":"Varian (Siemens Healthineers)","route":"/companies/varian/"}],"term":[{"id":"bone-metastases","kind":"term","name":"Bone metastases and skeletal-related events","route":"/terms/bone-metastases/"}],"trial":[{"id":"fast-02","kind":"trial","name":"FAST-02 (proton FLASH for thoracic bone metastases)","route":"/trials/fast-02/"}],"roadmap":[{"id":"particle-therapy-machines-roadmap","kind":"roadmap","name":"Particle therapy machines: from Loma Linda to proton rooms in a linac vault, carbon gantries and FLASH","route":"/roadmaps/particle-therapy-machines-roadmap/"}]}}