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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| external beam radiotherapy: Dose level 1 | Experimental | 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks) |
|
| external beam radiotherapy: dose level 2 | Experimental | 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks) |
|
| external beam radiotherapy: dose level 3 | Experimental | 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| external beam radiotherapy (EBRT) | Radiation | EBRT: 3 dose escalation levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale | 3 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging | 12 months after radiotherapy |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie Fonteyne, MD; PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.
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