Act.In.Sarc: An international randomized phase III trial of NBTXR3 in locally advanced soft tissue sarcoma

ASTRO, San Antonio, Texas · 2018, S. Bonvalot et al.


S. Bonvalot1, P. Rutkowski2, J. O. Thariat3, S. Carrere4, M. P. Sunyach5, E. Saada7, P. Ágoston7, A. Hong8, A. Mervoyer9, M. Rastrelli10, C. Le Pechoux11, V. Moreno12, R. Li13, B. Tiangco14, A. Casado15, A. Gronchi16, L. C. Mangel17, P. Hohenberger18, M. Delannes19, Z. Papai20

1 – Institut Curie, Paris, France
2 – Centrum Onkologii-Instytut im. Sklodowskiej-Curie w Warszawie, Warszawa, Poland
3 – Centre Baclesse, Caen, France
4 – Montpellier Cancer Institute, Montpellier, France
5 – Centre Leon Berard, Lyon, France
6 – Centre Antoine Lacassagne, Nice, France
7 – National Institute of Oncology, Budapest, Hungary
8 – Chris O’Brien Lifehouse, Camperdown, Australia
9 – Institut de Cancerologie de l’Ouest-Rene Gauducheau, Saint-Herblain, France
10 – Istituto Oncologico Veneto IRCCS, Padova, Italy
11 – Institut Gustave Roussy, Villejuif, France
12 – Hospital Fundación Jimenez Diaz, Madrid, Spain
13 – St. Luke’s Medical Center, Quezon City, Philippines
14 – The Medical City Cancer Center, Pasay City, Philippines
15 – Hospital Clinico Universitario San Carlos, Madrid, Spain
16 – Istituto Nazionale Tumori, Milan, Italy
17 – Pecs University, Pecs, Hungary
18 – Universitätsklinikum Mannheim, Mannheim, Germany
19 – Institut Claudius Regaud, Toulouse, France
20 – Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary


A subset of soft tissue sarcoma (STS) patients achieve significant therapeutic benefit from preoperative radiotherapy (RT). Yet, this treatment paradigm may be associated with limited efficacy and increased toxicity, highlighting the necessity of novel multimodal therapies aimed at local control with few adverse events (AEs). NBTXR3 is a first-in-class Hafnium-Oxide nanoparticle. Designed for cancer cell uptake, it is injected intratumorally (IT) and activated by ionizing radiation to yield a tumor-localized high energy deposit and increased cell death compared to the same dose of RT alone. We report now the first phase II/III randomized clinical trial of NBTXR3 given as preoperative treatment to patients with locally advanced STS of the extremity and trunk wall.

This trial met its primary and secondary endpoints of pCRR and R0 rates, respectively. NBTXR3 with RT demonstrated an acceptable safety profile compared to RT alone. As pCR is a known indicator of long-term treatment response with a positive correlation to both progression free and overall survival, NBTXR3 represent a new option for preoperative treatment for locally advanced STS.

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