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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.

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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.

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Randomisation was stratified by histological subtype myxoid liposarcoma vs others. This metastatic cancer no treatment an open-label study. The primary endpoint was the proportion of patients with a pathological complete response, assessed by a central pathology review board following European Organisation for Research and Treatment of Cancer guidelines in the intention-to-treat population full analysis set.

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Safety analyses were done in all patients who received at least one puncture and injection of NBTXR3 or at least one dose of radiotherapy. This study is registered with ClinicalTrials.

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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 deaths occurred.

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