ToxicityPhase 1NCT02748200
External Beam Radiotherapy for Muscle Invasive Bladder Cancer
A Phase 1 study testing external beam radiotherapy (EBRT) in people with Toxicity, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Toxicity
- What is being tested?
- external beam radiotherapy (EBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contra-indication for Diffusion-Weighted-Magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Toxicity
- Being tested
- external beam radiotherapy (EBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external beam radiotherapy (EBRT)Radiation
EBRT: 3 dose escalation levels
| Study group | Role | What they receive |
|---|---|---|
| external beam radiotherapy: Dose level 1 | Experimental | 57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks) Receives: Radiation: external beam radiotherapy (EBRT) |
| external beam radiotherapy: dose level 2 | Experimental | 60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks) Receives: Radiation: external beam radiotherapy (EBRT) |
| external beam radiotherapy: dose level 3 | Experimental | 62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks) Receives: Radiation: external beam radiotherapy (EBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale
Measured: 3 months after radiotherapy
Secondary outcomes (1)
Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging
Measured: 12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxicityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Fonteyne, MD; PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748200
- Sponsor's protocol ID
- 2015/0169
- Status last verified
- Dec 2022
- First submitted
- 18 Mar 2015
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Invasive Bladder Cancer: External Beam Radiotherapy as an Alternative for Cystectomy
- ClinicalTrials.gov ID
- NCT02748200
- Acronym / sponsor ID
- 2015/0169
- Conditions
- Toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All patients receive pelvic EBRT to the lymph nodes located along the common, internal, and external iliac artery; obturator fossa; and presacral nodes.
| Arm | Type | Receives |
|---|---|---|
| external beam radiotherapy: Dose level 1 | Experimental | Radiation: external beam radiotherapy (EBRT)57.6 Gray (Gy) (20 x 2.88 Gy, 5 fractions/week, 4 weeks) |
| external beam radiotherapy: dose level 2 | Experimental | Radiation: external beam radiotherapy (EBRT)60 Gy (20 x 3.00 Gy, 5 fractions/week, 4 weeks) |
| external beam radiotherapy: dose level 3 | Experimental | Radiation: external beam radiotherapy (EBRT)62.4 Gy (20 x 3.12Gy, 5 fractions/week, 4 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- contra-indication for Diffusion-Weighted-Magnetic resonance imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external beam radiotherapy (EBRT)EBRT: 3 dose escalation levels | Radiation | external beam radiotherapy: Dose level 1, external beam radiotherapy: dose level 2, external beam radiotherapy: dose level 3 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale
Time frame: 3 months after radiotherapy
1 secondary outcome
Number of participants free from local relapse assessed on cystoscopy and Magnetic Resonance Imaging
Time frame: 12 months after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Fonteyne, MD; PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing external beam radiotherapy (EBRT) in people with Toxicity, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by Radiation Therapy Oncology Group toxicity scale (time frame: 3 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.