Clinical trial · Interventional
Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment
Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment; a Prospective Randomized Phase III Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer (BC) | Malignant Bladder Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local hypo fractionated adaptive radiotherapy and Standard of Care | Radiation | — | UNRESOLVED |
| Standard of Care (Investigator Choice) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - RT and SoC
- description
- 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.
- interventionNames
- Radiation: Local hypo fractionated adaptive radiotherapy and Standard of Care
- type
- ACTIVE_COMPARATOR
- label
- Arm B - SoC
- description
- 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.
- interventionNames
- Other: Standard of Care (Investigator Choice)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Oral and written consent 2. Histologically confirmed MIBC with urothelial component 3. Male or female participants ≥ 18 years old 4. Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord. Exclusion Criteria: 1. Clinical Fragility Scale score ≥8 2. Previous pelvic RT with significant overlap 3. Visceral or bone metastases on CT scan 4. Multiple (\>3) lymph node metastases with a measurement of \>2 cm on CT scan 5. Planed for systemic treatment at the time of inclusion. 6. Local RT to the bladder indicated for the palliation of symptoms at the time of inclusion.
References
Publications (0)
Data not yet available