Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment

NCT07524426 | Not Yet Recruiting

• 1 other identifier: 2024-02857-01
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer (BC)

Keywords

LORUP; Bladder cancer; local radiotherapy; adaptive radiotherapy; Patient Reported Outcomes; Overall survival

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

Secondary Outcomes (8)

• Disease specific Survival

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

• Progression-free survival

  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

  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

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

• Health related quality of life, HRQoL

  Collected every fourth month throughout follow-up from randomization to 36 months of follow-up or until death of any cause, which ever comes first

Other Outcomes (1)

• Exploratory: blood and tissue biomarkers

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

Study Arms (2)

Arm A - RT and SoC

EXPERIMENTAL

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.

Radiation: Local hypo fractionated adaptive radiotherapy and Standard of Care

Arm B - SoC

ACTIVE COMPARATOR

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.

Other: Standard of Care (Investigator Choice)

Interventions

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.

Arm A - RT and SoC

Standard of Care (Investigator Choice) OTHER

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

Arm B - SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• Västerbotten County Council, Sweden: collaborator

Study Sites (1)

Norrlands University Hosital

Umeå, Västerbotten County, 90185, Sweden

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karin Söderkvist, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2034
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)