Clinical trial · Interventional
External Beam Radiotherapy for Muscle Invasive Bladder Cancer
Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy
- 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)
In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.
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 |
|---|---|---|---|
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| external beam radiotherapy (EBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- external beam radiotherapy: Dose level 1
- description
- 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)
- interventionNames
- Radiation: external beam radiotherapy (EBRT)
- type
- EXPERIMENTAL
- label
- external beam radiotherapy: dose level 2
- description
- 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)
- interventionNames
- Radiation: external beam radiotherapy (EBRT)
- type
- EXPERIMENTAL
- label
- external beam radiotherapy: dose level 3
- description
- 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * histological proven diagnosis of muscle invasive bladder cancer * stage \<T3b tumours with pathological lymph nodes after extended pelvic lymph node dissection * World Health Organisation performance state 0-2 * signed informed consent Exclusion Criteria: * contra-indication for Diffusion-Weighted-Magnetic resonance imaging
References
Publications (0)
Data not yet available