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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02447549
Registration number
NCT02447549
Ethics application status
Date submitted
11/05/2015
Date registered
19/05/2015
Date last updated
9/06/2020
Titles & IDs
Public title
Study of Tumour Focused Radiotherapy for Bladder Cancer
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Scientific title
A Randomised Phase II Trial of Adaptive Image Guided Standard or Dose Escalated Tumour Boost Radiotherapy in the Treatment of Transitional Cell Carcinoma of the Bladder
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Secondary ID [1]
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ICR-CTSU/2014/10049
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Universal Trial Number (UTN)
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Trial acronym
RAIDER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - WBRT
Treatment: Other - SART
Treatment: Other - DART
Active comparator: WBRT - Standard dose whole bladder radiotherapy
Experimental: SART - Standard dose Adaptive tumour focused radiotherapy (SART)
Experimental: DART - Dose escalated Adaptive tumour boost radiotherapy (DART)
Treatment: Other: WBRT
One RT plan with whole bladder treated to standard dose.
Treatment: Other: SART
Three plans (small, medium \& large) generated with the standard dose of RT focused on the tumour, sparing the normal bladder from full dose radiation. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.
Treatment: Other: DART
Three plans (small, medium \& large) generated with a higher dose than standard focused on the tumour and the remainder of the bladder treated to the same dose as in the SART group. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of participants meeting predefined radiotherapy dose constraints in DART group
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Assessment method [1]
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Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.
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Timepoint [1]
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4-6 weeks from randomisation
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Primary outcome [2]
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Proportion of patients experiencing severe late side effects following radiotherapy.
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Assessment method [2]
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Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.
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Timepoint [2]
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6-18 months post radiotherapy
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Secondary outcome [1]
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Clinician reported acute toxicity
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Assessment method [1]
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CTCAE v4
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Timepoint [1]
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0-6 months post radiotherapy
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Secondary outcome [2]
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Patient reported outcomes- symptomatic toxicity
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Assessment method [2]
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Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire
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Timepoint [2]
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0-24 months post radiotherapy
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Secondary outcome [3]
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Patient reported outcomes- urinary side effects
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Assessment method [3]
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King's Health Questionnaire (KHQ)
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Timepoint [3]
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0-24 months post radiotherapy
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Secondary outcome [4]
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Patient reported outcomes- sexual function
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Assessment method [4]
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excerpt of the EORTC QLQ-BLM30 questionnaire
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Timepoint [4]
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0-24 months post radiotherapy
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Secondary outcome [5]
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Patient reported outcomes- chronic gastrointestinal symptoms
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Assessment method [5]
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Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire
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Timepoint [5]
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0-24 months post radiotherapy
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Secondary outcome [6]
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Patient reported outcomes- health status
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Assessment method [6]
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EQ-5D questionnaire
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Timepoint [6]
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0-24 months post radiotherapy
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Secondary outcome [7]
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Loco-regional MIBC control
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Assessment method [7]
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Control of existing MIBC
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Timepoint [7]
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0-5 years post radiotherapy
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Secondary outcome [8]
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Progression free survival
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Assessment method [8]
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Freedom from progressive disease
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Timepoint [8]
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0-5 years post radiotherapy
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Secondary outcome [9]
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Overall survival
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Assessment method [9]
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Death from any cause
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Timepoint [9]
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0-5 years post radiotherapy
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Eligibility
Key inclusion criteria
* Written informed consent
* Age =16 years
* Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder
* Unifocal bladder TCC staged T2-T4a N0 M0*
* Fit to receive a radical course of radiotherapy
* WHO performance status 0-2
* Willing and able to comply with study procedures and follow up schedule *Tumour location must be clearly visible on imagine or recorded on a surgical bladder map
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Nodal or metastatic disease
* Multifocal invasive disease
* Simultaneous TCC in upper tract or urethra
* Pregnancy
* Active malignancy within 2 years of randomisation (not including non melanomatous skin carcinoma, previous non muscle invasive bladder tumours, NCCN low risk prostate cancer (T1/T2a, Gleason 6 PSA <10), in situ carcinoma of any site)
* Bilateral hip replacements
* Any other conditions that in the Principal Investigator's opinion would be a contra-indication to radiotherapy (e.g. previous pelvic radiotherapy / inflammatory bowel disease)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
345
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment hospital [2]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [3]
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Townsville General Hospital - Douglas
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Recruitment hospital [4]
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Radiation Oncology Mater Centre QLD - South Brisbane
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Recruitment hospital [5]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [6]
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Austin Hospital - Melbourne
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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- Wagga Wagga
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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- Douglas
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Recruitment postcode(s) [4]
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- South Brisbane
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Recruitment postcode(s) [5]
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- Hobart
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Recruitment postcode(s) [6]
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- Melbourne
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Recruitment postcode(s) [7]
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- Nedlands
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Recruitment outside Australia
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New Zealand
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State/province [1]
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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United Kingdom
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Devon
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United Kingdom
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England
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United Kingdom
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Essex
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United Kingdom
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Middlesex
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United Kingdom
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Scotland
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United Kingdom
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Adstone
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Bradford
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United Kingdom
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Brighton
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United Kingdom
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Brixton
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United Kingdom
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Bury St Edmunds
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United Kingdom
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Cambridge
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Cardiff
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Cheltenham
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Coventry
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Edinburgh
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Exeter
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Glasgow
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Guildford
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Leeds
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London
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Manchester
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Newcastle upon Tyne
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Norwich
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Oldham
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Peterborough
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United Kingdom
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Portsmouth
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Preston
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Sheffield
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Sutton-in-Ashfield
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United Kingdom
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Taunton
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United Kingdom
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Wakefield
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United Kingdom
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Wirral
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Funding & Sponsors
Primary sponsor type
Other
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Name
Institute of Cancer Research, United Kingdom
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Trans Tasman Radiation Oncology Group
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually treated either with surgical removal of the bladder, or daily radiotherapy treatment (high strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate methods which have the potential to improve how well this radiotherapy works. RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout treatment and treats the whole bladder with the same radiotherapy dose. In adaptive radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder. In RAIDER, at least 240 participants with muscle invasive bladder cancer will be in one of 3 treatment groups: 1. standard whole bladder radiotherapy 2. standard dose tumour focused adaptive radiotherapy 3. dose escalated tumour boost adaptive radiotherapy Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after radiotherapy and annually thereafter to check whether the cancer has returned and to receive treatment for any symptoms they may be experiencing. RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and to check that the long term side effects of the treatment are acceptable. If this is the case, results of RAIDER will be used to develop a study to establish whether dose escalated radiotherapy is better at treating bladder cancer than standard dose.
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Trial website
https://clinicaltrials.gov/study/NCT02447549
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Trial related presentations / publications
Hafeez S, Lewis R, Hall E, Huddart R; RAIDER Trial Management Group. Advancing Radiotherapy for Bladder Cancer: Randomised Phase II Trial of Adaptive Image-guided Standard or Dose-escalated Tumour Boost Radiotherapy (RAIDER). Clin Oncol (R Coll Radiol). 2021 Jun;33(6):e251-e256. doi: 10.1016/j.clon.2021.02.012. Epub 2021 Mar 23. No abstract available. Hafeez S, Webster A, Hansen VN, McNair HA, Warren-Oseni K, Patel E, Choudhury A, Creswell J, Foroudi F, Henry A, Kron T, McLaren DB, Mitra AV, Mostafid H, Saunders D, Miles E, Griffin C, Lewis R, Hall E, Huddart R. Protocol for tumour-focused dose-escalated adaptive radiotherapy for the radical treatment of bladder cancer in a multicentre phase II randomised controlled trial (RAIDER): radiotherapy planning and delivery guidance. BMJ Open. 2020 Dec 31;10(12):e041005. doi: 10.1136/bmjopen-2020-041005. Hafeez S, Lewis R, Griffin C, Hall E, Huddart R. Failing to Close the Gap Between Evidence and Clinical Practice in Radical Bladder Cancer Radiotherapy. Clin Oncol (R Coll Radiol). 2021 Jan;33(1):46-49. doi: 10.1016/j.clon.2020.07.001. Epub 2020 Aug 3. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Robert Huddart
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Address
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Institute of Cancer Research/RMNHSFT
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02447549
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