Adding targeted stereotactic body radiation therapy to standard systemic treatment for people with oligometastatic urothelial (bladder) carcinoma.

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

This study will test whether adding stereotactic body radiation therapy (SBRT) to usual systemic treatment helps people with urothelial (bladder) cancer who have up to three extracranial metastases.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Clinico Humanitas (other)
• Drugs / interventions: radiation, chemotherapy, immunotherapy
• Locations: 1 site (Rozzano, Milan)
• Trial ID: NCT07413523 on ClinicalTrials.gov

What this trial studies

This randomized trial enrolls adults with pathologically proven urothelial carcinoma and stage IV disease with no more than three extracranial metastases who are starting first- or second-line systemic therapy. Participants are assigned to receive standard systemic therapy alone or standard therapy plus metastasis-directed stereotactic body radiotherapy (SBRT), which delivers high radiation doses in a small number of sessions. The trial tracks safety, local control of treated metastases, and clinical outcomes during follow-up to determine whether adding SBRT improves disease control compared with systemic therapy alone. The study is conducted at a single specialized cancer center in Milan, Italy.

Who should consider this trial

Good fit: Adults (age >18) with pathologically confirmed urothelial carcinoma, WHO performance status 0–2, stage IV disease with up to three extracranial metastases, adequate organ function, and planned first- or second-line systemic therapy are the ideal candidates.

Not a fit: Patients with more widespread metastatic disease (>3 extracranial lesions), poor performance status (WHO PS ≥3), prior radiation to the same target lesions, recent other cancers, or those who are pregnant/breastfeeding are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, adding SBRT could better control metastatic sites and delay progression, potentially improving outcomes for patients with limited metastatic urothelial carcinoma.

How similar studies have performed: Stereotactic radiotherapy to oligometastases has shown benefits in other cancer types, but its role specifically in urothelial carcinoma is not yet well established.

Eligibility criteria

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

Where this trial is running

Rozzano, Milan

• IRCCS Humanitas Research Hospital — Rozzano, Milan, Italy (RECRUITING)

Study contacts

• Study coordinator: Marta Scorsetti, MD, Radiation oncologist

Conditions: Bladder Cancer, Urothelial Carcinoma, Oligometastasis, SBRT, SYSTEMIC TREATMENT, UROTHELIAL CARCINOMA, BLADDER CANCER, OLIGOMETASTASIS