Local radiotherapy for bladder cancer in patients not eligible for curative treatment
Official title: Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.
Run by Umeå University · NCT07524426 · Data updated 2026-11-12
This trial tests whether adding local hypofractionated adaptive radiotherapy to standard care can improve survival and reduce symptoms for bladder cancer patients who aren’t candidates for curative treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 248 (estimated) |
| Sponsor | Umeå University Academic / other |
| Drugs / interventions | immunotherapy, Radiation |
| Locations | 1 site (Umeå, Västerbotten County) |
| Status | Recruiting |
| Started | June 3, 2026 |
| Main results expected | June 2032 |
| Study ends | June 2034 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07524426 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed muscle-invasive bladder cancer who are not deemed to benefit from curative treatment and are considered suitable for local radiotherapy.
✕Probably not a fit
Patients with extensive metastases, poor performance status, or plans for systemic therapy at inclusion may derive limited or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study compares local, adaptive hypofractionated radiotherapy plus standard care versus standard care alone in adults with muscle-invasive bladder cancer who are not suitable for curative therapy. It uses modern radiotherapy techniques, including image guidance and treatment adaptation, to deliver effective but tolerable treatment. The trial is complemented by exploratory biomarker studies to identify potential predictors of prognosis and treatment response. The focus is on quality of life and survival in a population with high symptom burden and limited treatment options. Approximately 700 new bladder cancer patients are diagnosed annually in Sweden, and many older patients experience substantial comorbidity, underscoring the need for palliative, patient-centered approaches.
Why it matters
Potential benefit: If successful, patients could experience improved symptom control and longer survival with a tolerable, shorter, and more convenient radiotherapy approach.
How similar studies have gone: Previous studies in bladder cancer show mixed but encouraging signals for radiotherapy-based palliation improving symptoms and survival in selected patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Oral and written consent 2. Histologically confirmed MIBC with urothelial component 3. Male or female participants ≥ 18 years old 4. Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord. Exclusion Criteria: 1. Clinical Fragility Scale score ≥8 2. Previous pelvic RT with significant overlap 3. Visceral or bone metastases on CT scan 4. Multiple (\>3) lymph node metastases with a measurement of \>2 cm on CT scan 5. Planed for systemic treatment at the time of inclusion. 6. Local RT to the bladder indicated for the palliation of symptoms at the time of inclusion.
Where it's running
-
Norrlands University Hosital
Umeå, Västerbotten County, Sweden Recruiting
Study contacts
- Principal investigator: Karin Söderkvist, MD, PhD — Umeå University
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.