THE STUDY OBJECTIVES
Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients.
Increase the pathological complete response rate (pCR) of intratumoral injection of NBTXR3 activated by external beam radiation therapy (EBRT), versus EBRT alone in patients with locally advanced STS of the extremity and trunk wall.
Assess the safety profile of NBTXR3 activated by radiotherapy (incidence of early and late adverse events), to compare the objective response rate (ORR), tumor volume changes after NBTXR3 and carcinological resection rates, and to evaluate limb amputation rates.
Assess the tumor response, to evaluate the time-to-local recurrence, Local Recurrence Rate (LRR) at 12 months and to evaluate the time-to-distant recurrence and Distant-Recurrence Rate (DRR) at 12 months.
The interim evaluation was based on an analysis of the results of two-thirds of the patients included in the Phase II/III study – 104 patients were analyzed out of a total of 156. Based on the safety and available efficacy data, the IDMC has recommended the continuation of the Phase II/III trial of NBTXR3 in soft tissue sarcoma.
Primary Outcome Measures
Secondary Outcome Measures
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