A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
18 Years
N/A
Both
Bladder Cancer
Trial Information
A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
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.
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
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Compliance with Online Adaptive Radiation Therapy process
Outcome Description:
A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation
Outcome Time Frame:
From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Safety Issue:
No
Principal Investigator
Dr Farshad Foroudi
Investigator Role:
Study Chair
Investigator Affiliation:
Peter MacCallum Cancer Centre, Australia
Authority:
Australia: Human Research Ethics Committee
Study ID:
TROG 10.01
NCT ID:
NCT01142102
Start Date:
October 2010
Completion Date:
June 2015
Related Keywords:
- Bladder Cancer
- Bladder
- Radiotherapy
- Online
- Adaptive
- Urinary Bladder Neoplasms
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