Lancet Oncol ; 20 8 :Aug. This phase trial evaluated the safety and efficacy of the hafnium oxide HfO2 nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone as a pre-operative treatment in patients with locally advanced soft-tissue sarcoma. Sarc is a phase randomised, multicentre, international trial. Patients had to have a WHO performance status of and a life expectancy of at least 6 months.
Randomisation was stratified by histological subtype myxoid liposarcoma vs others. This was an open-label study.
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The primary endpoint was the proportion of patients with a pathological complete response, assessed by a central hepatic cancer etiology review board following European Organisation for Research and Treatment of Cancer guidelines in the intention-to-treat population full analysis set.
Safety analyses were done in all patients who received hepatic cancer etiology least one puncture and injection of NBTXR3 or at least one dose of radiotherapy.
This study is registered with ClinicalTrials. Two patients in the NBTXR3 group and one patient in the radiotherapy group were excluded from the efficacy analysis because they were subsequently discovered to be ineligible; thus, a total of patients were analysed for the primary endpoint in the intention-to-treat full analysis set 87 in the NBTXR3 group and 89 in the radiotherapy alone group. No treatment-related hepatic cancer etiology occurred.