A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Trans Tasman Radiation Oncology Group
- Enrollment
- 50
- Locations
- 12
- Primary Endpoint
- Compliance with Online Adaptive Radiation Therapy process
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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 M
- •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.
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Late normal tissue effects(Between 3 months and 3 years after the completion of radiation treatment)
- 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)
- Disease Free survival(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.(From start date of radiotherapy and within 3 months of completion of radiation treatment)
- 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.)
- Time to Local Bladder Failure(From date of enrolment to date of local bladder failure)