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Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment
Sponsor: Umeå University
Summary
The goal of this clinical trial is to improve the quality of life and prolong survival in bladder cancer patients unfit for curative treatment. The trial will compare the survival and symptoms of patients randomized to either local radiotherapy in addition to standard of care or standard of care alone. Using modern radiotherapy techniques, including hypofractionation and image-guided treatment adaptation, the aim is to deliver a well-tolerated, time-efficient, and effective treatment strategy for these patients. The trial collaborates with two ongoing exploratory biomarker studies collecting and analyzing potential biomarkers in urothelial bladder cancer. The hope is to provide biomarkers for prognosis and treatment response which is essential to ensure bladder cancer patients individualized treatment in the future, like those with breast and prostate cancer.
Official title: Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2026-06-03
Completion Date
2034-06
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
Local hypo fractionated adaptive radiotherapy and Standard of Care
Patients randomized to the radiotherapy (RT) arm will receive external beam radiotherapy to the whole urinary bladder as well as Standard of Care. Intensity-modulated Radiotherapy will be delivered using an adaptive treatment strategy, permitting either: * Plan-of-the-day (PoD) adaptive radiotherapy using a predefined library of plans, or * Online adaptive radiotherapy (oART) with daily re-contouring and re-optimisation to the anatomy of the day. The choice of adaptive strategy (PoD vs oART) and imaging modality (CBCT- or MR-based) is at institutional discretion, provided all protocol-specified target coverage objectives and organ-at-risk (OAR) constraints are met. The prescribed dose is 21 Gy in 3 fractions of 7 Gy, delivered every other day.
Standard of Care (Investigator Choice)
All applicable palliative treatments associated with the Standard of Care, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed
Locations (1)
Norrlands University Hosital
Umeå, Västerbotten County, Sweden