Stereotaxic Body Irradiation of Oligometastase in Sarcoma (Stereosarc)

Summary

Participation Requirements

Description

Open label, Phase II, prospective, multicentric, randomized study 2:1, 2 arm study designed to evaluate the efficacy of a Stereotactic Body Radiation Therapy treatment associated with immunotherapy versus a Stereotactic Body Radiation Therapy treatment only. Primary objective The primary objective i...

Open label, Phase II, prospective, multicentric, randomized study 2:1, 2 arm study designed to evaluate the efficacy of a Stereotactic Body Radiation Therapy treatment associated with immunotherapy versus a Stereotactic Body Radiation Therapy treatment only. Primary objective The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic irradiation in oligometastatic sarcoma patients. Secondary Objectives PFS by immune response criteria. ratio PFS after radiotherapy/PFS during the previous line of treatment Objective response rate. Rate of progression-free survival (PFS) at 6 months by line of treatment and histology. Evaluation of the toxicity of the treatment. Overall survival. Evaluation of the quality of life of patient treated by the combination of radio- and immunotherapy or radiotherapy only. Evaluation of the cost of treatment. Rate of PET-CT at inclusion Correlative study: Impact of biomarkers on clinical endpoints. Developing a mathematical models for STS treatment by SBRT + immunotherapy predictive of oligo versus poly metastatic evolution The treatment to be used in this study is the Atezolizumab concomitant with High Dose Radiation (SBRT) or the SBRT Alone Atezolizumab Subjects randomized in the experimental arm will receive Atezolizumab 1200 mg in combination with SBRT, Q3W (6 cycles) for 4 months until progression/completion. The Atezolizumab will be provided by the Sponsor (Centre Antoine Lacassagne). Chemotherapy will be discontinued in case of progression, unacceptable toxicity, or withdrawal of patient consent to receive study treatment. Radiation therapy SBRT can be performed with different equipments (CyberKnife, Truebeam, etc.). Adequate tumor tracking and patient setup/repositioning as well as online IGRT (image-guided radiation therapy) must be performed at each fraction. The maximal cumulative tumor diameter is 6 cm to maintain an advantageous risk-benefit ratio with SBRT. Two types of fractionation are proposed to account for tumor size and proximity of the tumor to sensitive organs at risk. Three fractions are proposed in favorable cases, 5 in more delicate cases. Fractions can be performed on consecutive days. Depending on cases, they may be delivered every other day; the whole SBRT duration should not exceed 3 weeks.

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