Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
NCT ID: NCT01142102
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2010-10-31
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Radiation Therapy
Radiation Therapy
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.
Interventions
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Radiation Therapy
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
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Dr Farshad Foroudi
Role: STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Mater Hospital
Brisbane, Queensland, Australia
Townsville Hospital
Douglas, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Peter MacCallum Cancer Centre - Box Hill
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre - Morrabbin
Melbourne, Victoria, Australia
Alfred Hospital
Prahran, Victoria, Australia
Christchurch Hospital
Christchurch, , New Zealand
Waikato Hospital
Waikato, , New Zealand
Countries
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Related Links
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Click here for more information about this study on the TROG official website
Other Identifiers
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ACTRN12610000711011
Identifier Type: REGISTRY
Identifier Source: secondary_id
TROG 10.01
Identifier Type: -
Identifier Source: org_study_id
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