{"entity":{"id":"fast-02","kind":"trial","name":"FAST-02 (proton FLASH for thoracic bone metastases)","aka":["FAST-02 trial"],"tldr":"The second human study of ultra-fast proton radiotherapy, this time for painful bone metastases in the chest wall, close to the lungs and heart. Ten patients were treated with no moderate or worse side effects.","summary":"FAST-02 enrolled 12 patients and treated 10 with single-fraction proton FLASH to the rib or scapula. Average time on the table was 14.6 minutes. At a median follow-up of 189 days there were no grade 2 or worse acute or late adverse events at least possibly related to FLASH; pain responded completely in six and partly in three, and three patients reported pain flares. The registry lists the study as active, not recruiting.","status":"active","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT05524064","url":"https://clinicaltrials.gov/study/NCT05524064"},{"label":"Daugherty et al., FAST-02: proton FLASH for thoracic bone metastases (Radiotherapy and Oncology 2026)","url":"https://doi.org/10.1016/j.radonc.2026.111671"}],"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":["fast-01"],"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":"NCT05524064","phase":"not-applicable","setting":"Adults with one to three painful non-vertebral bone metastases in the rib or scapula, treated with 8 Gy proton FLASH at 40 Gy per second or more, under FDA investigational device exemption G220086","sponsor":"Varian, a Siemens Healthineers Company","result":"No grade 2 or worse FLASH-related adverse events in 10 treated patients; complete pain response in 6.","started":"2023-03-08","startedType":"actual","yearReported":2026,"enrolled":12,"enrolledBasis":"registered","enrolledNote":"12 patients were enrolled and 10 treated in the 2026 report; ClinicalTrials.gov NCT05524064 gives an estimated 10.","outcomes":[]},"route":"/trials/fast-02/","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-01","kind":"trial","name":"FAST-01 (proton FLASH for bone metastases)","route":"/trials/fast-01/"}],"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/"}]}}