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Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Oral and written consent

• Histologically confirmed MIBC with urothelial component

• Male or female participants ≥ 18 years old

• Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord.

Locations
Other Locations
Sweden
Norrlands University Hosital
RECRUITING
Umeå
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2034-06
Participants
Target number of participants: 248
Treatments
Experimental: Arm A - RT and SoC
Local hypo fractionated adaptive radiotherapy to the bladder, 7 Gy in 3 fractions delivered every other day (eod) prescribed in addition to standard of care.
Active_comparator: Arm B - SoC
Standard of care. All applicable palliative treatments, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed.
Related Therapeutic Areas
Sponsors
Leads: Umeå University
Collaborators: Västerbotten County Council, Sweden

This content was sourced from clinicaltrials.gov