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


Trial ID
ACTRN12613000774729
Ethics application status
Not yet submitted
Date submitted
17/06/2013
Date registered
10/07/2013
Date last updated
10/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Bladder Adaptive Radiotherapy (BART) Trial - A study on the feasibility of BART.


Scientific title
Bladder Adaptive Radiotherapy (BART) Trial - From Bladder Online Adaptive Radiotherapy (BOLART) to BART: A study on the feasibility of BART (Where less is perhaps more)



Secondary ID [1] 282632 0
Nil
Universal Trial Number (UTN)
Trial acronym
BART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 289326 0
Condition category
Condition code
Cancer 289668 289668 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
What is BART and what does it involve?

Radiotherapy uses high-energy radiation to kill cancer cells by damaging their DNA.

Bladder adaptive radiotherapy (BART) is a specialized technique that utilizes computed tomography (CT) scans to visualize the bladder, and therefore allow optimal matching of a radiotherapy treatment plan on a daily basis. Adaptive radiotherapy is particularly useful in the treatment of bladder cancer, given the significant daily variability in the location and size of the bladder. The technique of daily optimization of treatment plans allows smaller volumes to be treated and therefore less toxicity to surrounding normal organs (such as small & large bowel).

The dosage amount and frequency of radiotherapy administered in this trial will not differ from standard ‘non-adaptive’ treatment that you would otherwise receive if you declined participation in the trial. These parameters will be determined by your Radiation Oncologist. In the large majority of cases, radiotherapy will be given as 5 treatments per week (daily from Monday to Friday), as part of a 4-7 week treatment course.

BOLART refers to an ongoing study of adaptive image-guided radiotherapy for muscle invasive bladder cancer that is being carried out by the Trans-Tasman Radiation Oncology Group. We have adapted the BOLART protocol to allow the adaptive radiotherapy technique to commence from day 1 rather than day 8. This adjustment allows the benefits of adaptive radiotherapy to be realised earlier on in the treatment. We have also modified from BOLART the method of optimization of treatment plans, which we theorise from our experience should allow easier and tighter matching to the ‘best fit of the day’.

The duration of radiotherapy treatment will be determined by your Radiation Oncologist, but will generally range from 4-7 weeks. Follow-up review will be conducted by treating Radiation Oncology team at 4-6 weeks after completion of radiotherapy, and at 6, 12, 18, and 24 months post-treatment.

Intervention code [1] 287299 0
Treatment: Other
Comparator / control treatment
NA - This is a single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289749 0
To assess feasibility to treat Bladder Cancer using Adaptive Bladder Radiotherapy. (BART) - Assessing the size of the bladder prior to treament with Cone Beam Computer Tomography (CBCT) and adjust treatment, accordingly on a daily basis.
Timepoint [1] 289749 0
Assessed on a daily basis prior to administration of radiotherapy for the duration of the treament period.
Secondary outcome [1] 303182 0
A secondary endpoint of acute toxicity related to the treatment will also be examined and recorded, using CTCAE V 4.0.
Timepoint [1] 303182 0
4-6 weeks post BART

Eligibility
Key inclusion criteria
Aged 18 years or older
Histologically confirmed muscle invasive bladder cancer (any pathology)
Stage T2-3b N0 M0
Considered suitable for definitive radiotherapy with or without concurrent chemotherapy
Has provided written Informed Consent for participation in this trial
An ECOG performance status score of 2 or less
Life expectancy greater than 5 years
Participants capable of childbearing are using adequate contraception
Available for follow up
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other active malignancy
Previous pelvic radiotherapy
Clinical or radiological evidence of nodal or distant metastases
Women who are pregnant or lactating

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)
Eligible patients will be see in the Oncology Clinic and approached by the Oncologist. Those consented will have single arm treatment.
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
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1094 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 6947 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 287411 0
Hospital
Name [1] 287411 0
Royal Prince Alfred Hospital
Address [1] 287411 0
Missenden Road
Camperdown NSW 2050
Country [1] 287411 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 286157 0
None
Name [1] 286157 0
Address [1] 286157 0
Country [1] 286157 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289386 0
Sydney Local Health District Ethics Review Committee
Ethics committee address [1] 289386 0
Suite 210 (a) RPAH Medical Centre
100 Carillon Ave
Newtown NSW 2060
Ethics committee country [1] 289386 0
Australia
Date submitted for ethics approval [1] 289386 0
11/06/2013
Approval date [1] 289386 0
Ethics approval number [1] 289386 0

Summary
Brief summary
The study is evaluating the feasibility and toxicity of the refined bladder adaptive radiotherapy (BART) protocol. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have histologically confirmed muscle invasive bladder cancer (any pathology), stage T2-3b N0 M0, considered suitable for definitive radiotherapy with or without concurrent chemotherapy, an ECOG performance status score of 2 or less, have a life expectancy greater than 5 years, and available for follow-up. Trial details Participants in this study will be administered Bladder adaptive radiotherapy (BART). BART is a specialized technique that utilizes computed tomography (CT) scans to visualize the bladder, and therefore allow optimal matching of a radiotherapy treatment plan on a daily basis. Adaptive radiotherapy is particularly useful in the treatment of bladder cancer, given the significant daily variability in the location and size of the bladder. The technique of daily optimization of treatment plans allows smaller volumes to be treated and therefore less toxicity to surrounding normal organs (such as small & large bowel). The dosage amount and frequency of radiotherapy administered in this trial will not differ from standard ‘non-adaptive’ treatment that you would otherwise receive if you declined participation in the trial. These parameters will be determined by your Radiation Oncologist. In the large majority of cases, radiotherapy will be given as 5 treatments per week (daily from Monday to Friday), as part of a 4-7 week treatment course. The duration of radiotherapy treatment will be determined by your Radiation Oncologist, but will generally range from 4-7 weeks. Follow-up review will be conducted by treating Radiation Oncology team at 4-6 weeks after completion of radiotherapy, and at 6, 12, 18, and 24 months post-treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40586 0
A/Prof George Hruby
Address 40586 0
Dept of Radiation Oncology
RPAH
Missenden Rd
Camperdown NSW 2050
Country 40586 0
Australia
Phone 40586 0
+61295158057
Fax 40586 0
Email 40586 0
ghruby@email.cs.nsw.gov.au
Contact person for public queries
Name 40587 0
Miss Fiona McCafferty
Address 40587 0
Clinical Trials
Dept of Radiation Oncology RPAH
Missenden Rd
Camperdown NSW 2050
Country 40587 0
Australia
Phone 40587 0
+61295153414
Fax 40587 0
Email 40587 0
fiona.mccafferty@sswahs.nsw.gov.au
Contact person for scientific queries
Name 40588 0
Dr Raymond Wu
Address 40588 0
Dept of Radiation Oncology
RPAH
Missenden Rd
Camperdown NSW 2050
Country 40588 0
Australia
Phone 40588 0
+61295158057
Fax 40588 0
Email 40588 0
raymond@wu.id.au