Table 3. Overview of ongoing clinical trials involving FLASH radiotherapy

NCT identifier Cancer Design Population Estimated enrollment Radiation source Treatment Primary endpoint Status1) (study start date)
NCT04986696 Malignant melanoma Phase INon-randomizedDose escalation Multiple skin metastasesPD after systemic treatment 46 Electrons 7 dose levels (22, 24, 26, 28, 30, 32, and 34 Gy in a single fraction) MTD or RP2D Recruiting (July 1, 2021)
NCT05524064 Bone metastasis Phase ISingle arm 1–3 symptomatic bone metastasis in the thorax 10 Protons 8 Gy in a single fraction ToxicityPatient-reported pain reliefPain medication use Recruiting (March 8, 2023)
NCT05724875 Skin cancer Phase IIRandomized T1-2N0M0 cutaneous squamous cell carcinoma or basal cell carcinoma 60 Electrons FLASH-RTvs.Conventional RT (T1, 22 Gy in a single fraction; T2, 30 Gy in 5 fractions) Skin toxicity (≥grade 3)Local control rate Recruiting (June 22, 2023)
NCT, National Clinical Trial; PD, progressive disease; MTD, maximum tolerated dose; RP2D, recommended phase II dose; RT, radiotherapy.
From https://clinicaltrials.gov/ (accessed on July 26, 2024).