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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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, it wil be used to treat oligometastatic disease
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy
RECRUITINGSBRT 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
Time frame: From treatment to 12 months follow up
SBRT Toxicities
assessment of treatment-related toxicities following the CTCAE V. 4.0 scale
Time frame: From treatment to 12 months follow up
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.
Time frame: from treatment to 12 months follow up
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.
Time frame: from treatment to 12 months follow up
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