Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer (BOLART)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer|
- Compliance with Online Adaptive Radiation Therapy process [ Time Frame: From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days) ] [ Designated as safety issue: No ]A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation
- Pattern of failure and competing risks analysis [ Time Frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial ] [ Designated as safety issue: No ]Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
- Disease Free survival [ Time Frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial ] [ Designated as safety issue: No ]Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
- 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. [ Time Frame: From start date of radiotherapy and within 3 months of completion of radiation treatment ] [ Designated as safety issue: Yes ]Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.
- Quality of Life [ Time Frame: Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment. ] [ Designated as safety issue: No ]Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.
- Late normal tissue effects [ Time Frame: Between 3 months and 3 years after the completion of radiation treatment ] [ Designated as safety issue: Yes ]Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.
- Time to Local Bladder Failure [ Time Frame: From date of enrolment to date of local bladder failure ] [ Designated as safety issue: No ]Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Radiation: 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.
This is a single-arm multicentre feasibility trial in which the primary aim is to determine the compliance rate of patients to online adaptive radiotherapy for muscle invasive bladder cancer over multiple Australian and New Zealand centres. The compliance rate is defined as the proportion of patients successfully completing treatment without a major protocol deviation.
Subject to the accrual being at least 40 patients in the first 2 years, accrual will continue until a total of 50 patients have been accrued. If this accrual target is not met, then consideration will be given to stopping the trial early due to poor accrual. Each patient will be followed-up until 2 years after the last patient's date of accrual. Assessments for toxicity and recurrence or progression will take place at four weeks after completion of treatment, then three monthly from the end of treatment for the first 12 months and then 6 monthly thereafter.
|Contact: Dr Narmatha Kuru, PhD||+61 03 9656 email@example.com|
|Australia, New South Wales|
|Royal Prince Alfred Hospital||Recruiting|
|Camperdown, New South Wales, Australia, 2050|
|Contact: Dr Nitya Patanjali +61 02 9515 8057 Nitya.Patanjali@sswahs.gov.au|
|Principal Investigator: Nitya Patanjali|
|Calvary Mater Newcastle||Recruiting|
|Newcastle, New South Wales, Australia, 2298|
|Contact: Dr Colin Tang +61 02 4014 3631 firstname.lastname@example.org|
|Principal Investigator: Colin Tang|
|Westmead, New South Wales, Australia, 2145|
|Contact: Sandra Turner|
|Principal Investigator: Sandra Turner|
|Brisbane, Queensland, Australia, 4101|
|Contact: Dr Kumar Gogna +61 07 3840 3255 Kumar_Gogna@health.gov.au|
|Principal Investigator: Kumar Gogna|
|Douglas, Queensland, Australia, 4814|
|Contact: Dr Alex Tan +61 07 4796 1602 Alex_Tan@health.qld.gov.au|
|Principal Investigator: Alex Tan|
|Princess Alexandra Hospital||Recruiting|
|Woolloongabba, Queensland, Australia, 4102|
|Contact: Margot Lehman|
|Principal Investigator: Margot Lehman|
|Royal Hobart Hospital||Recruiting|
|Hobart, Tasmania, Australia, 7000|
|Contact: Marketa Skala +61 3 6222 8626|
|Principal Investigator: Marketa Skala|
|Peter MacCallum Cancer Centre - Box Hill||Recruiting|
|Melbourne, Victoria, Australia, 3128|
|Contact: Dr Farshad Foroudi +61 03 9656 1090 email@example.com|
|Principal Investigator: Farshad Foroudi|
|Peter MacCallum Cancer Centre - Morrabbin||Recruiting|
|Melbourne, Victoria, Australia, 3165|
|Contact: Dr Keen Hun Tai +61 03 9656 1063 KeenHun.Tai@petermac.org|
|Principal Investigator: Keen Hun Tai|
|Prahran, Victoria, Australia, 3181|
|Contact: Dr Jeremy Millar +61 03 9076 2337 firstname.lastname@example.org|
|Principal Investigator: Jeremy Millar|
|Christchurch, New Zealand, 4710|
|Contact: Dr Stephen Williams email@example.com|
|Principal Investigator: Stephen Williams|
|Waikato, New Zealand, 3240|
|Contact: Leanne Tyrie|
|Principal Investigator: Leanne Tyrie|
|Study Chair:||Dr Farshad Foroudi||Peter MacCallum Cancer Centre, Australia|