Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Radiation: Radiation Therapy
- Registration Number
- NCT01142102
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Radiation Therapy Radiation Therapy
- Primary Outcome Measures
Name Time Method Compliance with Online Adaptive Radiation Therapy process 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
- Secondary Outcome Measures
Name Time Method Pattern of failure and competing risks analysis 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 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. 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 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 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 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.
Trial Locations
- Locations (12)
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Newcastle, New South Wales, Australia
Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Waikato Hospital
🇳🇿Waikato, New Zealand
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre - Box Hill
🇦🇺Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre - Morrabbin
🇦🇺Melbourne, Victoria, Australia
Alfred Hospital
🇦🇺Prahran, Victoria, Australia
Mater Hospital
🇦🇺Brisbane, Queensland, Australia