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Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA: ASTRA Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Marta Scorsetti, MD, Radiation oncologist
marta.scorsetti@hunimed.eu
+39 0282248524
Backup
Ciro Franzese, MD, Radiation oncologist
ciro.franzese@hunimed.eu
+39 0282247454
Time Frame
Start Date: 2026-02-16
Estimated Completion Date: 2030-02
Participants
Target number of participants: 44
Treatments
No_intervention: ONLY SYSTEMIC TREATMENT
patients will be treated according to clinical practice with systemic treatment only
Experimental: SBRT
patients will be treated with systemic treatment and SBRT on oligometastatic lesions
Related Therapeutic Areas
Sponsors
Collaborators: Varian, a Siemens Healthineers Company
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov