A MULTICENTER RANDOMIZED,
OPEN LABEL STUDY
A multicenter randomized, open-label study, to compare the efficacy of NBTXR3, implanted as intratumor injection and activated by radiotherapy, versus radiotherapy alone in patients with locally Advanced Soft Tissue Sarcoma of the Extremity and Trunk Wall.
Patients who will be allocated in arm A, will receive a single intratumor injection of NBTXR3 and will receive external beam radiotherapy starting 24hrs after the injection up to completion of 5 weeks, 5 days a week of treatment (50Gy, 2Gy/fraction). Then, all patients will undergo surgical resection of the tumor 5 weeks later and will be followed for wound Healing and toxicity assessment. A visit of end of treatment will take place approximately 3-4 weeks after surgery. Patients will be followed for evaluation of their disease status and adverse event until the end of study.
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