Act.In.Sarc
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.
Overview
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.
Of 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.
The 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.
- 16 vs 8 out of 100 had no cancer left at surgery with NBTXR3 plus radiotherapy compared with Radiotherapy alone; 8 more per 100.
- Roughly one extra person helped for every 13 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.044) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
180 enrolled.
14 of 87; intention-to-treat full analysis set · 7 of 89
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response (central review, EORTC guidelines)primary | NBTXR3 plus radiotherapy | 87 | 16% | - | 0.044 | link |
| Radiotherapy alone | 89 | 8% |
Similar pages
not linked directly; found by shared links- CancerRetroperitoneal sarcoma
- TechnologyHyperthermia
Shares Radiosensitisers, Sarcomas (soft tissue, bone, GIST).
- CancerLiposarcoma