Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
BOLART
A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
2 other identifiers
interventional
50
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJanuary 24, 2017
January 1, 2017
2.3 years
May 27, 2010
January 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Secondary Outcomes (6)
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.
Late normal tissue effects
Between 3 months and 3 years after the completion of radiation treatment
- +1 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALRadiation Therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Mater Hospital
Brisbane, Queensland, 4101, Australia
Townsville Hospital
Douglas, Queensland, 4814, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Peter MacCallum Cancer Centre - Box Hill
Melbourne, Victoria, 3128, Australia
Peter MacCallum Cancer Centre - Morrabbin
Melbourne, Victoria, 3165, Australia
Alfred Hospital
Prahran, Victoria, 3181, Australia
Christchurch Hospital
Christchurch, 4710, New Zealand
Waikato Hospital
Waikato, 3240, New Zealand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dr Farshad Foroudi
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2010
First Posted
June 11, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2013
Study Completion
June 1, 2015
Last Updated
January 24, 2017
Record last verified: 2017-01