{"entity":{"id":"act-in-sarc","kind":"trial","name":"Act.In.Sarc","aka":["NBTXR3-301","ActInSarc"],"tldr":"Act.In.Sarc showed that injecting hafnium oxide nanoparticles into a soft-tissue sarcoma before preoperative radiotherapy roughly doubled the share of patients whose tumour, once removed, had almost no surviving cancer cells, and that result supported the product's European CE mark in 2019.","summary":"Act.In.Sarc (study NBTXR3-301) was an open-label, randomised, multicentre phase 2/3 trial of NBTXR3, a hafnium oxide nanoparticle radioenhancer injected once into the tumour, in adults with locally advanced soft-tissue sarcoma of the extremity or trunk wall who needed preoperative radiotherapy. 180 eligible patients were randomised 1:1, stratified by histological subtype (myxoid liposarcoma versus others), to NBTXR3 (an injection volume equal to 10 percent of the baseline tumour volume, at 53.3 g/L) followed by external-beam radiotherapy of 50 Gy in 25 fractions, or to the same radiotherapy alone; both arms then had surgery. The primary endpoint was pathological complete response, judged by a central pathology review board under EORTC guidelines in the intention-to-treat full analysis set.\n\nOf 179 patients who started treatment, 176 were analysed for the primary endpoint (87 NBTXR3, 89 radiotherapy alone) after three were found to be ineligible. Pathological complete response occurred in 14 of 87 patients (16 percent) with NBTXR3 and 7 of 89 (8 percent) with radiotherapy alone (p=0.044; The Lancet Oncology 2019). Postoperative wound complication was the most common grade 3 or 4 treatment-emergent event in both arms (9 percent each). Injection-site pain and hypotension (4 percent each) were the most common grade 3 or 4 events related to NBTXR3 administration; serious adverse events occurred in 39 percent versus 30 percent, and there were no treatment-related deaths.\n\nThe final safety and quality-of-life report (International Journal of Radiation Oncology, Biology, Physics 2022) restated the primary result as 16.1 versus 7.9 percent, reported more R0 resections with NBTXR3 (77.0 versus 64.0 percent), and found no negative effect on safety or quality of life over at least two years of follow-up. NBTXR3 carries a European CE mark, as Hensify, for this indication since 2019.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02379845","url":"https://clinicaltrials.gov/study/NCT02379845"},{"label":"The Lancet Oncology 2019","url":"https://doi.org/10.1016/S1470-2045(19)30326-2"},{"label":"International Journal of Radiation Oncology, Biology, Physics 2022 (final safety and quality of life)","url":"https://doi.org/10.1016/j.ijrobp.2022.07.001"}],"tags":[],"related":[],"cancers":["sarcoma"],"sections":[],"technologies":["radiosensitisers"],"targets":[],"drugs":["nbtxr3"],"companies":["nanobiotix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sylvie-bonvalot"],"bottlenecks":[],"keyPapers":["paper-act-in-sarc-lancet-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02379845","phase":"2/3","setting":"Locally advanced soft-tissue sarcoma of the extremity or trunk wall needing preoperative radiotherapy: a single intratumoural injection of NBTXR3 before 50 Gy in 25 fractions, against the same radiotherapy alone, then surgery in both arms","sponsor":"Nanobiotix","result":"Pathological complete response 16% (14 of 87) with NBTXR3 plus radiotherapy versus 8% (7 of 89) with radiotherapy alone (p=0.044).","yearReported":2019,"enrolled":180,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response (central review, EORTC guidelines)","primary":true,"unit":"%","arms":[{"name":"NBTXR3 plus radiotherapy","n":87,"value":16,"note":"14 of 87; intention-to-treat full analysis set"},{"name":"Radiotherapy alone","n":89,"value":8,"note":"7 of 89"}],"p":"0.044","source":"https://doi.org/10.1016/S1470-2045(19)30326-2"}]},"route":"/trials/act-in-sarc/","neighbours":{"cancer":[{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"radiosensitisers","kind":"technology","name":"Radiosensitisers","route":"/technologies/radiosensitisers/"}],"drug":[{"id":"nbtxr3","kind":"drug","name":"NBTXR3 (hafnium oxide nanoparticles)","route":"/drugs/nbtxr3/"}],"company":[{"id":"nanobiotix","kind":"company","name":"Nanobiotix","route":"/companies/nanobiotix/"}],"person":[{"id":"sylvie-bonvalot","kind":"person","name":"Sylvie Bonvalot","route":"/people/sylvie-bonvalot/"}],"paper":[{"id":"paper-act-in-sarc-lancet-oncol-2019","kind":"paper","name":"NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial","route":"/key-papers/paper-act-in-sarc-lancet-oncol-2019/"}]}}