Bladder Cancer, Oligometastasis, Urothelial Carcinoma (UC)
Conditions
Keywords
SBRT, SYSTEMIC TREATMENT, UROTHELIAL CARCINOMA, BLADDER CANCER, OLIGOMETASTASIS, RADIOTHERAPY
Brief summary
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.
Interventions
RADIATIONSBRT
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
Sponsors
Istituto Clinico Humanitas
Varian, a Siemens Healthineers Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SBRT Outcome | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SBRT Toxicities | From treatment to 12 months follow up | assessment of treatment-related toxicities following the CTCAE V. 4.0 scale |
| quality of life of treated patients | from treatment to 12 months follow up | 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 | from treatment to 12 months follow up | 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. |
Countries
Italy
Contacts
CONTACTMarta Scorsetti, MD, Radiation oncologist
CONTACTCiro Franzese, MD, Radiation oncologist
Outcome results
None listed