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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Local hypo fractionated adaptive radiotherapy and Standard of Care
Radiation
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)
Other intervention
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

Treatment groups

248 Participants

are divided into 2 treatment groups

Group A: Arm A - RT and SoCExperimental treatment 1 intervention

Group B: Arm B - SoCActive comparator 1 intervention

Trial outcomes

Primary outcomes

Overall Survival

Time frame

From date of randomization until the date of death from any cause assessed up to a minimum of 36 months

Secondary outcomes

Disease specific Survival

Time frame

From date of randomization until the date of death by MIBC assessed up to a minimum of 36 months

Progression-free survival

Any symptoms associated with tumor progression, including but not restricted to the AESI of the study.

Time frame

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to a minimum of 36 months

Radiological progression-free survival

Defined as; 1. new lesion as compared to baseline and/or 2) increase of longest tumour diameter by 20% as assessed by local investigator.

Time frame

Time from randomization to the date of the first documented radiological progression or death, whichever comes first, assessed up to a minimum of 36 months

Start of systemic anti-tumour treatment

Start of any systemic anti-tumour treatment, such as immunotherapy, tyrosine kinase inhibitors, chemotherapy or antibody-conjugates

Time frame

Time from randomization to start of systemic anti-tumour treatment assessed up to a minimum of 36 months

Other outcomes

Exploratory: blood and tissue biomarkers

The correlation of treatment (RT) outcome and blood and tissue biomarkers

Time frame

Collected at baseline, 4-week and 8 weeks of follow-up from randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Västerbotten County Council, Sweden

Collaborator

Source ClinicalTrials.gov

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