Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000484448p
Ethics application status
Not yet submitted
Date submitted
30/04/2025
Date registered
20/05/2025
Date last updated
20/05/2025
Date data sharing statement initially provided
20/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the use of higher doses of targeted radiation and combined treatments in local control of bladder cancer care.
Scientific title
Investigating the use of Stereotactic Ablative Body Radiation (SABR) Dose Escalation and Tri-Modality Treatment in Muscle-Invasive Bladder Cancer (MIBC) on local disease control outcomes.
Secondary ID [1] 314324 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Bladder Boost
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 337277 0
Condition category
Condition code
Cancer 333675 333675 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Delivery of SABR dose escalation of 8-10Gy in 1 single session prior to standard course of radiotherapy with or without chemotherapy.
The SABR session is prescribed by the Clinical Investigator (radiation oncologist) and delivered by the qualified radiation therapist.
SABR session takes approximately 45 minutes to deliver.
SABR session will be scheduled to occur the week prior to standard radiotherapy (at least 2 days and a maximum of 7 days between SABR and standard radiotherapy).
All treatment will be recorded on the record and verify system of the department to ensure delivery of the treatment as per prescribed by the trial clinician.
Intervention code [1] 330933 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341267 0
Local control (disease free survival) of bladder cancer
Timepoint [1] 341267 0
The outcome will be assessed at baseline, 3, 9, 15, 21, 27 months post radiotherapy and annually up to 5 years post radiotherapy
Secondary outcome [1] 446976 0
Acute and late toxicities assess as a composite secondary outcome.
Timepoint [1] 446976 0
Toxicities will be assessed at baseline, weekly during radiotherapy treatment, 3, 9, 12, 15, 21, 24 and 27 months and annually up to 5 years post radiotherapy

Eligibility
Key inclusion criteria
Histological or radiological diagnosis of muscle-invasive urothelial carcinoma of the bladder (T2-4a) of any grade.
Presence or absence of pelvic nodal disease (N0-2).
No signs of distant metastasis (M0).
Older than 18 years.
Suitable for radical radiotherapy.
Medically inoperable or refused to undergo radical cystectomy.
Able to provide voluntary informed consent and comply with the protocol for the duration of the study including undergoing treatment and scheduled visit and examination and follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Distant metastasis/uncontrolled systemic disease which would preclude the patient from the study.
Previous pelvic radiotherapy.
Previous radical cystectomy.
Other malignancy within the previous 2 years (other than adequately treated BCC of the skin or adequately treated in situ carcinoma of the cervix uteri).
Previous malignancy that is likely to interfere with protocol treatment or follow up for a minimum of two years.
Inflammatory bowel disease.
Pregnancy.
Contraindications to MRI or inability to undergo MRI scanning.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2028
Actual
Date of last data collection
Anticipated
1/09/2033
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27849 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 27850 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 44044 0
2170 - Liverpool
Recruitment postcode(s) [2] 44045 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 318843 0
Self funded/Unfunded
Name [1] 318843 0
Country [1] 318843 0
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321293 0
None
Name [1] 321293 0
Address [1] 321293 0
Country [1] 321293 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317460 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317460 0
Ethics committee country [1] 317460 0
Australia
Date submitted for ethics approval [1] 317460 0
30/05/2025
Approval date [1] 317460 0
Ethics approval number [1] 317460 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141106 0
Dr Anzela Anzela
Address 141106 0
Liverpool Cancer Therapy Centre, Locked Bag 7103, Liverpool BC NSW 1871
Country 141106 0
Australia
Phone 141106 0
+61 02 87389805
Fax 141106 0
Email 141106 0
[email protected]
Contact person for public queries
Name 141107 0
Penny Phan
Address 141107 0
Ingham Institute, 1 Campbell St Liverpool. NSW 2170
Country 141107 0
Australia
Phone 141107 0
+61 429094402
Fax 141107 0
Email 141107 0
[email protected]
Contact person for scientific queries
Name 141108 0
Penny Phan
Address 141108 0
Ingham Institute, 1 Campbell St Liverpool. NSW 2170
Country 141108 0
Australia
Phone 141108 0
+61 429094402
Fax 141108 0
Email 141108 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.