Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT in Oligo-metastatic/Persistent/Recurrent Ovarian Cancer (MPR-OC): a Prospective, Multicenter Phase II Study (MITO-RT3/RAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 20
- 主要终点
- Clinical complete response to SBRT by imaging
研究概览
简要总结
This is a prospective, multicenter, Phase II study aimed at defining the activity and safety of SBRT in MPR-OC. Clinical and imaging data as well as SBRT parameters would be analyzed with the aim to identify potential predictors of response to treatment and clinical outcome.
详细描述
Stereotactic Body Radiotherapy (SBRT) represents the cutting edge within high conformal and modulated radiotherapy techniques; it can provide high local control (LC) for curative-intent of low burden metastatic, persistent and metastatic lesions in face of minimal acute and late toxicities. SBRT is amenable even in patients who had already been managed by radiotherapy. In addition, SBRT has been shown to be active in chemoresistant disease, and potentially able to mount immune response through the release of tumor neoantigens after cell killing, thus allowing to synergize with immunotherapeutic approaches. SBRT has been widely adopted in the clinical setting of oligometastatic/persistent/recurrent (MPR) disease (up to <5 lesions) in several malignancies including also ovarian cancer (OC); the recently published retrospective, multicenter Italian study (MITO-RT1) has confirmed the activity and safety of SBRT in MPR OC, thus providing a model able to predict the higher chance of complete response of tumor lesions to SBRT, and local control rate.
The MITO-RT3/RAD trial is a prospective, Italian multicenter Phase II study aimed at evaluating the activity and safety of SBRT in MPR-OC patients. Clinical and imaging data, as well as SBRT technical parameters, would be analyzed with the aim to identify potential predictors of response to treatment and clinical outcome: in this context, additional insights into the tissue features of tumor lesions would be of clinical interest in the context of the personalized treatment, as testified by studies demonstrating that image-based quantitative features from pre-treatment imaging could predict clinical outcomes in several malignancies.
Furthermore, given the crucial role played by the mutational status of BRCA 1/2 genes in this disease, the assessment of BRCA gene status was considered mandatory, thus representing inclusion criteria.
The study will include patients with oligo-metastatic/persistent/recurrent lesions (MPR) from OC patients for which salvage surgery or other local therapies resulted not feasible, as per relative contraindication to further systemic therapy because of serious comorbidities, as per previous severe toxicity, unavailability of potentially active chemotherapy, or patient refusal of systemic therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ovarian cancer
- •age >18 yrs,
- •ECOG performance status 0-3,
- •expected life expectancy >6 months,
- •1-5 synchronous lesions
- •any site of disease,
- •compulsory assessment of mutational status of BRCA1/2 genes (either germline or somatic),
- •salvage surgery or other local therapies not feasible,
- •relative contraindication to further systemic therapy because of serious comorbidities,
- •previous severe systemic therapy toxicity
- •unavailability of potentially active systemic therapy,
- •patient refusal of systemic therapy,
- •Re-treatment of lesions already treated with conventional external beam radiotherapy is allowed*
排除标准
- •mucinous OC,
- •borderline ovarian tumors,
- •non-epithelial OC,
- •previous radiotherapy severe toxicity
- •co-morbidities and functional impairment considered clinically precluding the safe use of SBRT,
- •pregnancy
- •any psychological, sociological, or geographical issue potentially hampering compliance with the study,
- •lesion diameter larger than 5 centimeters
结局指标
主要结局
Clinical complete response to SBRT by imaging
时间窗: Assessment of Clinical complete response at six months
Radiologic response will be evaluated by morphological (contrast-enhanced CT scan and/or MRI) or functional imaging modalities (18F-fluorodeoxyglucose-PET) and classified according to the RECIST (version 1.1) or PERCIST criteria.
次要结局
- 2-yr actuarial LC rate(2 years)
- 2-yr progression-free survival(2 years)
- 2-yr overall survival(2 years)
- rate of toxicity(2 years)
- treatment free interval(2 years)
- 2-yr actuarial late toxicity free survival(2 years)
研究者
Gabriella Macchia
Radiation Oncologist
Gemelli Molise Hospital