Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment
ConditionBladder Cancer (BC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Clinical Fragility Scale score ≥8
Previous pelvic RT with significant overlap
Visceral or bone metastases on CT scan
Multiple (>3) lymph node metastases with a measurement of >2 cm on CT scan
Trial design
Treatments tested in this trial
- Local hypo fractionated adaptive radiotherapy and Standard of Care
- Standard of Care (Investigator Choice)
Treatment groups
248 Participants
are divided into 2 treatment groupsSponsors and collaborators
Umeå University
Lead sponsor
Västerbotten County Council, Sweden
Collaborator
Source ClinicalTrials.gov