NCT07413523 Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA
| NCT ID | NCT07413523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2030-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-02-16 with a primary completion date of 2030-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07413523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07413523 currently recruiting?
Yes, NCT07413523 is actively recruiting participants. Contact the research team at marta.scorsetti@hunimed.eu for enrollment information.
Where is the NCT07413523 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT07413523 clinical trial?
NCT07413523 is sponsored by Istituto Clinico Humanitas. The trial plans to enroll 44 participants.
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