Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France.
clinical research department, UNICANCER, Paris, Île-de-France, France.
BMJ Open. 2020 Sep 23;10(9):e038391. doi: 10.1136/bmjopen-2020-038391.
Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.
STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.
The trial is registered on ClinicalTrials.gov (ID: NCT03548428).
This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.
高达 50%的软组织肉瘤（STS）患者在疾病过程中会发生转移。细胞毒性疗法是该情况下的标准治疗方法，但一线治疗的平均肿瘤缓解率为 25%，而后续线的缓解率≤10%。在寡转移阶段，立体定向体部放射治疗（SBRT）可实现治疗部位的高控制率（≥80%），并且在总生存方面与手术的疗效相当。为了通过多部位照射使肿瘤平衡向抗肿瘤免疫转移，可以将放射治疗与免疫抑制途径的抑制剂联合使用。
STEREOSARC 是一项前瞻性、多中心、随机的 II 期研究，旨在评估 SBRT 联合免疫治疗与单纯 SBRT 治疗寡转移肉瘤患者的疗效。通过 2:1 的比例在两个治疗组内进行随机分组。主要目的是评估免疫调节立体定向多部位照射在寡转移肉瘤患者中的疗效，以 6 个月时的无进展生存期（PFS）率为评价指标。次要目的包括免疫反应标准下的 PFS、总生存期、生活质量评估以及建立预测寡转移与多转移演变的肿瘤生长和扩散的数学模型。患者将被随机分为两组：SBRT 联合阿替利珠单抗和单纯 SBRT。预计纳入的患者总数应为 103 例。
该试验已在 ClinicalTrials.gov 上注册（编号：NCT03548428）。
该研究于 2019 年 10 月 18 日获得法国南部和海外医学伦理委员会（CPP2019-09-076-PP）的批准，并于 2019 年 9 月 18 日获得法国国家药品和健康产品安全局（MEDAECNAT-2019-08-00004_2017-004239-35）的批准。结果将根据患者的个人要求或通过科学会议的新闻稿进行传播。结果将通过科学会议和出版物进行交流。
