NCT07413523Recruiting
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial 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
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 16 Feb 2026
- Primary completion date
- Feb 2030
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Bladder cancer
- NCT number
- NCT07413523
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 16 Feb 2026 to the primary completion date, Feb 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation therapy on the same target lesions
Other illness
- 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
Other
- Inability to provide informed consent
- Pregnant or breastfeeding patients
- WHO PS \>=3
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.