Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA: ASTRA Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- SBRT Outcome
研究概览
简要总结
Bladder cancer is the most common type of urothelial cancer. When the disease has spread to other parts of the body (metastatic disease), the prognosis is often poor, because there are only a few effective treatment options available.
At the moment, standard treatment mainly includes systemic therapies, such as chemotherapy and immunotherapy (immune checkpoint inhibitors). These treatments act on the whole body. However, the use of local treatments, such as stereotactic radiotherapy, has not been well studied in bladder cancer.
Stereotactic radiotherapy is a type of radiation treatment that delivers very high doses of radiation to the tumor in a small number of treatment sessions. This technique is already widely used to treat a limited number of metastases (called oligometastases) from other types of cancer.
The aim of this study is to understand whether stereotactic radiotherapy is also effective and safe for treating oligometastases coming from bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •WHO performance status ≤ 2
- •Pathological proven urothelial carcinoma
- •Stage IV disease at imaging
- •Maximum of 3 extracranial metastases
- •Indication to receive I or II line of standard systemic therapy
- •Adequate liver function
- •Adequate bone marrow function
- •Written informed consent
排除标准
- •Inability to provide informed consent
- •Previous radiation therapy on the same target lesions
- •Pregnant or breastfeeding patients
- •Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)
- •Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study
- •WHO PS >=3
研究组 & 干预措施
ONLY SYSTEMIC TREATMENT
patients will be treated according to clinical practice with systemic treatment only
SBRT
patients will be treated with systemic treatment and SBRT on oligometastatic lesions
干预措施: SBRT (Radiation)
结局指标
主要结局
SBRT Outcome
时间窗: From treatment to 12 months follow up
evaluation of the effectiveness of treatment through conventional imaging. The response will be classified according to RECIST (Response Evaluation Criteria in Solid Tumours, version 1.1) and PERCIST13 criteria
次要结局
- SBRT Toxicities(From treatment to 12 months follow up)
- quality of life of treated patients(from treatment to 12 months follow up)
- immune response in patients treated with SBRT(from treatment to 12 months follow up)