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

NCT07524426 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-05-26

No results posted yet for this study

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)

Interventions

RADIATION

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.

OTHER

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

Sponsors & Collaborators

  • Västerbotten County Council, Sweden

    collaborator OTHER_GOV

  • Umeå University

    lead OTHER

Principal Investigators

  • Karin Söderkvist, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2032-03-31
Completion
2034-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524426 on ClinicalTrials.gov