Clinical trial NCT01142102: Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
Official title: A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder
Radiotherapy
Online
Adaptive
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Compliance with Online Adaptive Radiation Therapy process
timeFrame: From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Secondary outcomes:
measure: Pattern of failure and competing risks analysis
timeFrame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
measure: Disease Free survival
timeFrame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
measure: 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.
timeFrame: From start date of radiotherapy and within 3 months of completion of radiation treatment
measure: Quality of Life
timeFrame: Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment.
measure: Late normal tissue effects
timeFrame: Between 3 months and 3 years after the completion of radiation treatment
measure: Time to Local Bladder Failure
timeFrame: From date of enrolment to date of local bladder failure
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Hospital
state: Queensland
city: Douglas
country: Australia
facility: Townsville Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre - Box Hill
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre - Morrabbin
state: Victoria
city: Prahran
country: Australia
facility: Alfred Hospital
state: Victoria
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Waikato
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Dr Farshad Foroudi
role: STUDY_CHAIR
References: