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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Compliance with Online Adaptive Radiation Therapy process
A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation
Time frame: From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Pattern of failure and competing risks analysis
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Time frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Disease Free survival
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Time frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
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.
Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.
Time frame: From start date of radiotherapy and within 3 months of completion of radiation treatment
Quality of Life
Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.
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.
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Mater Hospital
Brisbane, Queensland, Australia
Townsville Hospital
Douglas, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Peter MacCallum Cancer Centre - Box Hill
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre - Morrabbin
Melbourne, Victoria, Australia
Alfred Hospital
Prahran, Victoria, Australia
...and 2 more locations
Late normal tissue effects
Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.
Time frame: Between 3 months and 3 years after the completion of radiation treatment
Time to 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.
Time frame: From date of enrolment to date of local bladder failure