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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01142102




Registration number
NCT01142102
Ethics application status
Date submitted
27/05/2010
Date registered
11/06/2010
Date last updated
24/01/2017

Titles & IDs
Public title
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
Scientific title
A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
Secondary ID [1] 0 0
ACTRN12610000711011
Secondary ID [2] 0 0
TROG 10.01
Universal Trial Number (UTN)
Trial acronym
BOLART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiation Therapy

Experimental: Arm 1 - Radiation Therapy


Treatment: Other: Radiation Therapy
A radical dose of radiotherapy to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 treatment days.
Conventional plan is used to deliver treatment for fractions 1 to 7 using a standard planning approach and a CTV to PTV margin of 1.5cm.
Adaptive plan is used to deliver treatment for fractions 8 through 32 using the same standard techniques as for fractions 1 to 7 but using one of three specific CTV volumes,namely: small, average or large. In all these cases the CTV to PTV margin is 0.7cm. Image guidance using a treatment unit based verification CT unit (Cone Beam CT or CT on Rails)based on soft tissue delineation is used to position the treatment fields and select the plan to best cover the CTV.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compliance with Online Adaptive Radiation Therapy process
Timepoint [1] 0 0
From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Secondary outcome [1] 0 0
Pattern of failure and competing risks analysis
Timepoint [1] 0 0
From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Secondary outcome [2] 0 0
Disease Free survival
Timepoint [2] 0 0
From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Secondary outcome [3] 0 0
Acute Toxicity of >/= grade 3 (NCI CTCAE version 4.0) of gastointestinal, diarrhoea, nausea, vomiting, colitis, proctitis, renal/genitourinary, cyctitis non-infective, haematuria, uinary frequency, urinary urgency and urinary retension.
Timepoint [3] 0 0
From start date of radiotherapy and within 3 months of completion of radiation treatment
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment.
Secondary outcome [5] 0 0
Late normal tissue effects
Timepoint [5] 0 0
Between 3 months and 3 years after the completion of radiation treatment
Secondary outcome [6] 0 0
Time to Local Bladder Failure
Timepoint [6] 0 0
From date of enrolment to date of local bladder failure

Eligibility
Key inclusion criteria
- Aged 18 years or older

- Has provided written Informed Consent for participation in this trial

- Histologically confirmed muscle invasive bladder cancer.

- Transitional cell, squamous cell, adenocarcinoma or mixed histology. Stage T2-4 N0 M0.

- An ECOG performance status score of 2 or less (see appendices).

- Life expectancy greater than 6 months.

- Considered suitable for radical radiotherapy.

- Participants capable of childbearing are using adequate contraception.

- Radiotherapy must be able to be commenced within 12 weeks of surgery.

- Available for follow up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant or lactating.

- Previous pelvic radiotherapy

- Previous cystectomy

- A small contracted bladder

- Unilateral or bilateral hip replacement

- Small cell histology

- Clinical or radiological evidence of nodal or distant metastases

- Presence of indwelling urinary catheter

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Mater Hospital - Brisbane
Recruitment hospital [5] 0 0
Townsville Hospital - Douglas
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - Box Hill - Melbourne
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Morrabbin - Melbourne
Recruitment hospital [10] 0 0
Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3128 - Melbourne
Recruitment postcode(s) [9] 0 0
3165 - Melbourne
Recruitment postcode(s) [10] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The principal objective of the trial is to test the hypothesis that Online Adaptive
Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation
Oncology departments.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01142102
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr Farshad Foroudi
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01142102