External Beam Radiotherapy for Muscle Invasive Bladder Cancer
December 22, 2022 updated by: University Hospital, Ghent
Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
- Level 1: 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks); BED: 61 Gy.
- Level 2: 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks); BED: 64 Gy
- Level 3: 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks); BED: 67 Gy. Fiducials will be implanted at the edges of the postoperative bed during the second transurethral resection of the bladder to improve visualization of the gross tumor volume (GTV) during external beam radiotherapy (EBRT) and consequently improve treatment delivery accuracy. In order to further improve the treatment accuracy, 5 planning Computed Tomographies and plans, with different bladder fillings will be made upfront in our study. During treatment the plan corresponding best with bladder filling at time of EBRT will be selected and delivered.
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: external beam radiotherapy: Dose level 1
57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks)
|
EBRT: 3 dose escalation levels
|
|
Experimental: external beam radiotherapy: dose level 2
60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks)
|
EBRT: 3 dose escalation levels
|
|
Experimental: external beam radiotherapy: dose level 3
62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks)
|
EBRT: 3 dose escalation levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale
Time Frame: 3 months after radiotherapy
|
3 months after radiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging
Time Frame: 12 months after radiotherapy
|
12 months after radiotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Valérie Fonteyne, MD; PhD, University Hospital, Ghent
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2014
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimate)
April 22, 2016
Study Record Updates
Last Update Posted (Actual)
December 27, 2022
Last Update Submitted That Met QC Criteria
December 22, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/0169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.