Actively Recruiting
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA
Led by Istituto Clinico Humanitas · Updated on 2026-04-30
44
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
I
Istituto Clinico Humanitas
Lead Sponsor
V
Varian, a Siemens Healthineers Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- WHO performance status ≤ 2
- Pathologically confirmed urothelial carcinoma
- Stage IV disease confirmed by imaging
- Maximum of 3 extracranial metastases
- Scheduled to receive first or second line standard systemic therapy
- Adequate liver function
- Adequate bone marrow function
- Provided written informed consent
You will not qualify if you...
- Unable to provide informed consent
- Previous radiation therapy on the same target lesions
- Pregnant or breastfeeding
- Prior malignancy within the last 5 years except certain treated skin or cervical cancers or localized prostate cancer without progression
- Mental conditions preventing understanding of the study
- WHO performance status ≥ 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
Research Team
M
Marta Scorsetti, MD, Radiation oncologist
CONTACT
C
Ciro Franzese, MD, Radiation oncologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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