Bladder CancerBOLARTNCT01142102
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
A study testing Radiation Therapy in people with Bladder Cancer, run by Trans Tasman Radiation Oncology Group at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2010to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Australia10 sites
Mater Hospital
Brisbane, Queensland, 4101
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Townsville Hospital
Douglas, Queensland, 4814
Royal Hobart Hospital
Hobart, Tasmania, 7000
Peter MacCallum Cancer Centre - Box Hill
Melbourne, Victoria, 3128
Peter MacCallum Cancer Centre - Morrabbin
Melbourne, Victoria, 3165
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Alfred Hospital
Prahran, Victoria, 3181
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand2 sites
Christchurch Hospital
Christchurch, 4710
Waikato Hospital
Waikato, 3240
About this study
Official title: A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Radiation Therapy
- Keywords
- Bladder, Radiotherapy, Online, Adaptive
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Radiation Therapy Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Measured: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Disease Free survival
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Measured: 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.
Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.
Measured: From start date of radiotherapy and within 3 months of completion of radiation treatment
Quality of Life
Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.
Measured: 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
Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.
Measured: Between 3 months and 3 years after the completion of radiation treatment
Time to Local Bladder Failure
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Measured: From date of enrolment to date of local bladder failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Farshad Foroudi, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142102
- Sponsor's protocol ID
- TROG 10.01
- Other IDs
- ACTRN12610000711011
- Acronym
- BOLART
- Status last verified
- Jan 2017
- First submitted
- 27 May 2010
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT01142102
- Acronym / sponsor ID
- BOLART / TROG 10.01
- Conditions
- Bladder Cancer
- Keywords
- Bladder, Radiotherapy, Online, Adaptive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: Radiation TherapyRadiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (8 listed)
- Women who are pregnant or lactating.
- Previous pelvic radiotherapy
- Previous cystectomy
- A small contracted bladder
- Unilateral or bilateral hip replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyA 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. | Radiation | Arm 1 |
Primary outcome
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
6 secondary outcomes
Pattern of failure and competing risks analysis
Time frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Disease Free survival
Time frame: 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.
Time frame: From start date of radiotherapy and within 3 months of completion of radiation treatment
Quality of Life
Time frame: 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
Time frame: Between 3 months and 3 years after the completion of radiation treatment
Time to Local Bladder Failure
Time frame: From date of enrolment to date of local bladder failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Farshad Foroudi study chair
Peter MacCallum Cancer Centre, Australia
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Bladder Cancer, run by Trans Tasman Radiation Oncology Group at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.