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.
Age > 18 years
WHO performance status ≤ 2
Pathological proven urothelial carcinoma
Stage IV disease at imaging
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)
Parallel
SBRT
RadiationStereotactic radiotherapy is a type of radiation treatment that delivers very high doses of radiation to the tumor in a small number of treatment sessions, it wil be used to treat oligometastatic disease
SBRT Outcome
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
SBRT Toxicities
assessment of treatment-related toxicities following the CTCAE V. 4.0 scale
quality of life of treated patients
Quality of life will be scored using the Quality of life questionnaire (QLQ)-C30. a low score means a good quality of life while high values indicate a poor quality of life.
immune response in patients treated with SBRT
Monitoring of the dynamics of innate (monocytic and granulocytic cells, Natural killer cells) and adaptive (T cells, B cells) immune subsets in the peripheral blood of patients before and after RT.
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Istituto Clinico Humanitas
Lead sponsor
Varian, a Siemens Healthineers Company
Collaborator
