THE STUDY OUTLINE
Patients with locally advanced (soft tissue sarcoma) STS have very limited therapeutic options. Today, a standard treatment of care before surgery is radiotherapy aiming to reduce the tumor volume. Thereafter surgery is still required to remove the tumor. But despite radiotherapy, a considerable proportion of patients have advanced tumors that cannot be resected in their entirety. The remaining tumor mass promotes the further development of the disease resulting in a poor prognosis for the patient.
Based on current available data, there is a reasonable hope that NBTXR3 could potentially improve radiotherapy efficacy, destroying locally advanced tumors more efficiently and to improve the quality of surgery enabling a more complete removal of the tumor.
The effect of NBTXR3 in patients with locally advanced STS is now explored in an international multi-center study around 30 clinical sites (hospitals) throughout Europe, Canada, South Africa and Asia-Pacific (once all authorizations are obtained).
Precisely, the study will compare the antitumor activity of NBTXR3 (administered by intratumoral injection) and radiotherapy compared with radiotherapy alone. To do so, the study has two treatment arms, one treatment arm enrolling patients receiving NBTXR3 and radiotherapy, the other treatment arm with patients receiving radiotherapy. Patients in both treatment arms will have a regular protocol which means five weeks of radiotherapy, followed by surgical resection of the tumor.
All patients will be closely monitored to collect data for the objectives of the study. The primary objective of this study is to observe an increased tumor cell death rate in the arm with NBTXR3 plus radiotherapy versus radiotherapy alone. Further objectives evaluate tumor specific endpoints to compare both treatment arms.
An Independent Data Monitoring Committee (IDMC) is in charge to ensure the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design.
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