Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer (BOLART)
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|ClinicalTrials.gov Identifier: NCT01142102|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : January 24, 2017
|Condition or disease||Intervention/treatment|
|Bladder Cancer||Radiation: Radiation Therapy|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer|
|Study Start Date :||October 2010|
|Primary Completion Date :||February 2013|
|Study Completion Date :||June 2015|
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.
- 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) ]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 ]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 ]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 ]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. ]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 ]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 ]Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142102
|Australia, New South Wales|
|Royal Prince Alfred Hospital|
|Camperdown, New South Wales, Australia, 2050|
|Calvary Mater Newcastle|
|Newcastle, New South Wales, Australia, 2298|
|Westmead, New South Wales, Australia, 2145|
|Brisbane, Queensland, Australia, 4101|
|Douglas, Queensland, Australia, 4814|
|Princess Alexandra Hospital|
|Woolloongabba, Queensland, Australia, 4102|
|Royal Hobart Hospital|
|Hobart, Tasmania, Australia, 7000|
|Peter MacCallum Cancer Centre - Box Hill|
|Melbourne, Victoria, Australia, 3128|
|Peter MacCallum Cancer Centre - Morrabbin|
|Melbourne, Victoria, Australia, 3165|
|Prahran, Victoria, Australia, 3181|
|Christchurch, New Zealand, 4710|
|Waikato, New Zealand, 3240|
|Study Chair:||Dr Farshad Foroudi||Peter MacCallum Cancer Centre, Australia|