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Trial registered on ANZCTR


Registration number
ACTRN12610000711011
Ethics application status
Approved
Date submitted
9/06/2010
Date registered
26/08/2010
Date last updated
24/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 10.01 - A multi-centre feasibility study of online adaptive image guided radiotherapy for muscle invasive bladder cancer
Secondary ID [1] 252468 0
clinicaltrials.gov ID: NCT01142102
Universal Trial Number (UTN)
Trial acronym
BOLART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Invasive Bladder Cancer 257549 0
Condition category
Condition code
Cancer 257710 257710 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiation Therapy
A radical dose of radiotherapy (RT) to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 days.
Conventional plan is used to deliver treatment for fractions 1-7 using a standard planning approach and a Clinical Target Volume (CTV) to Planning Target Volume (PTV) margin of 1.5cm.
Adaptive plan is used to deliver treatment for fractions 8-32 using the same standard techniques as for fractions 1-7 but using one of the three specific CTV's, namely: small, average and large. In all these cases the CTV to PTV margin is 0.7cm. Image guidence using a treatment unit based verification Computed Tomography (CT) unit (cone beam CT or CT on rails) based on soft tissue delinieation is used to position the traetment fields and select the plan to best cover the CTV.
Intervention code [1] 256638 0
Treatment: Other
Comparator / control treatment
N/A - this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258608 0
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.
A major protocol deviation will be considered to have occurred for any patient for whom the following 3 conditions applies:
1. All 3 adaptive treatment plans (small, average, and large) were found to be inadequate for more than 10% of treatment fractions, necessitating use of the conventional plan for those treatment fractions. Since the adaptive treatment plans must be available for fractions 10-32 inclusive, this means that using the conventional plan for three or more of these fractions would constitute a Major
Protocol Deviation.
2. Three adaptive plans cannot be created and quality assured in time for the patients 10th fraction.
3. Post treatment imaging shows that the Clinical Target Volume (CTV) has expanded beyond the Planning Target Volume (PTV) chosen in any one of the treatment fractions where post treatment imaging is conducted (namely fractions 10,15,20,25,30).
Timepoint [1] 258608 0
Patients will be monitored on a daily basis, from the start date of radiotherapy to the last day of radiotherapy treatment (approximately 6 weeks and 2 days)
Secondary outcome [1] 264511 0
Time to local bladder failure. Documented by biopsy within the bladder or by cystoscopic assessment (Cystoscopy performed at baseline, every 3 months following radiotherapy for 12 months, then every six months following radiotherapy until trial ends)
Timepoint [1] 264511 0
From date of enrolment until a local failure or regional nodal recurrence. (Cystoscopy performed at baseline, every 3 months following radiotherapy for 12 months, then every six months following radiotherapy until trial ends)
Secondary outcome [2] 264512 0
Pattern of failure. Assessed clinically and with imaging where appropriate.
Timepoint [2] 264512 0
From date of enrolment until a local failure or regional nodal recurrence. Patients will be assessed at Baseline, weekly during radiotherapy (where applicable), 1 month following radiotherapy, 3 months following radiotherapy, then every three months until 12 months following radiotherapy reached; at 12 months following radiotherapy then every three months until 2 year follow up is completed
Secondary outcome [3] 264513 0
Disease Free survival. Assessed clinically and with imaging where appropriate.
Timepoint [3] 264513 0
From date of enrolment until a local failure or regional nodal recurrence. Patients will be assessed at Baseline, weekly during radiotherapy (where applicable), 1 month following radiotherapy, 3 months following radiotherapy, then every three months until 12 months following radiotherapy reached; at 12 months following radiotherapy then every three months until 2 year follow up is completed
Secondary outcome [4] 264514 0
Acute Toxicity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) version 4.0
Timepoint [4] 264514 0
Patients will be assessed weekly during radiotherapy, then at 1 month and 3 months following radiotherapy.
Secondary outcome [5] 264515 0
Quality of Life (QoL) measured using appropriate QoL questionnaires. Assessment of Quality of life - 8 Dimensional (AQoL-8D), European Organisation for research and treatment of cancer Quality of Life Questionnaire (EORTC QLQ C30), European Organisation for research and treatment of cancer Quality of Life Questionnaire Bladder Module (EORTC QLQ BLM30) and EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D).
Timepoint [5] 264515 0
within 2 weeks prior to commencement of treatment, during the last week of traetment, 1 and 18 Months after the completion of treatment.
Secondary outcome [6] 264516 0
Late Normal Tissue effects using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) version 4.0
Timepoint [6] 264516 0
Measured between 3 months and 3 years after the completion of radiation treatment. Patients will be assesed at 3 months following radiation, then every 3 months until 2 years post radiation treatment, then 6 monthly for 12 months.
Secondary outcome [7] 264517 0
Overall Survival. Assessed clinically and with imaging where appropriate.
Timepoint [7] 264517 0
From start date of treatment until death due to any cause. Patients will be assessed at Baseline, weekly during radiotherapy (where applicable), 1 month following radiotherapy, 3 months following radiotherapy, then every three months until 12 months following radiotherapy reached; at 12 months following radiotherapy then every three months until 2 year follow up is completed

Eligibility
Key inclusion criteria
1. Aged 18 years or older 2. Has provided written Informed Consent for participation in this trial 3. Histologically confirmed muscle invasive bladder cancer. 4. Transitional cell, squamous cell, adenocarcinoma or mixed histology. Stage T2-4 N0 M0. 5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. 6. Life expectancy greater than 6 months. 7. Considered suitable for radical radiotherapy.
8. Participants capable of childbearing are using adequate contraception. 9. Radiotherapy must be able to be commenced within 12 weeks of surgery. 10. Available for follow up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or lactating. 2. Previous pelvic radiotherapy 3. Previous cystectomy 4. A small contracted bladder 5. Unilateral or bilateral hip replacement 6. Small cell histology 7.Clinical or radiological evidence of nodal or distant metastases 8. Presence of indwelling urinary catheter

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To register a patient the following documents should be faxed to the Trial Coordinating Centre.
- Enrolment and Eligibility Case Report Forms (CRFs)
- De-identified copy of the consent form (by blacking out the participant’s name, only leaving the initials)

On receipt of the faxed enrolment, eligibility and consent forms, the trial centre will review documents. Once the eligibility is confirmed the investigator will be advised that the patient is enrolled in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2010
Actual
16/08/2010
Date of last participant enrolment
Anticipated
Actual
1/12/2012
Date of last data collection
Anticipated
Actual
18/06/2015
Sample size
Target
50
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1397 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 1398 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 1399 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [4] 1400 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 1401 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 1402 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [7] 1403 0
The Townsville Hospital - Douglas
Recruitment hospital [8] 1404 0
Westmead Hospital - Westmead
Recruitment hospital [9] 1405 0
The Alfred - Prahran
Recruitment outside Australia
Country [1] 5269 0
New Zealand
State/province [1] 5269 0
Christchurch
Country [2] 5270 0
New Zealand
State/province [2] 5270 0
Auckland
Country [3] 5271 0
New Zealand
State/province [3] 5271 0
Waikato

Funding & Sponsors
Funding source category [1] 257118 0
Government body
Name [1] 257118 0
National Health and Medical Research Council (NHMRC)
Country [1] 257118 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Calvary Mater Newcastle
Locked Bag 7 Hunter Region Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 256379 0
None
Name [1] 256379 0
Address [1] 256379 0
Country [1] 256379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259159 0
Peter MacCallum Human Research Ethics Committee
Ethics committee address [1] 259159 0
Ethics committee country [1] 259159 0
Australia
Date submitted for ethics approval [1] 259159 0
Approval date [1] 259159 0
06/04/2010
Ethics approval number [1] 259159 0
10/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31277 0
Dr Farshad Foroudi
Address 31277 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
VIC
3002
Country 31277 0
Australia
Phone 31277 0
+61 3 96561111
Fax 31277 0
Email 31277 0
farshad.foroudi@petermac.org
Contact person for public queries
Name 14524 0
Christine Russell
Address 14524 0
Centre for Biostatistics and Clinical Trials (BaCT)
Level 2, No. 10
St Andrew's Place
East Melbourne
VIC 3002
Country 14524 0
Australia
Phone 14524 0
+61 3 96563661
Fax 14524 0
Email 14524 0
christine.russell@petermac.org
Contact person for scientific queries
Name 5452 0
Farshad Foroudi
Address 5452 0
Perter MacCallum Cancer Centre
St Andrew's Place East Melbourne VIC 3002
Country 5452 0
Australia
Phone 5452 0
+61 3 96561111
Fax 5452 0
Email 5452 0
farshad.foroudi@petermac.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.