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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
ICR-CTSU/2014/10049
Universal Trial Number (UTN)
Trial acronym
RAIDER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants meeting predefined radiotherapy dose constraints in DART group
Timepoint [1] 0 0
4-6 weeks from randomisation
Primary outcome [2] 0 0
Proportion of patients experiencing severe late side effects following radiotherapy.
Timepoint [2] 0 0
6-18 months post radiotherapy
Secondary outcome [1] 0 0
Clinician reported acute toxicity
Timepoint [1] 0 0
0-6 months post radiotherapy
Secondary outcome [2] 0 0
Patient reported outcomes- symptomatic toxicity
Timepoint [2] 0 0
0-24 months post radiotherapy
Secondary outcome [3] 0 0
Patient reported outcomes- urinary side effects
Timepoint [3] 0 0
0-24 months post radiotherapy
Secondary outcome [4] 0 0
Patient reported outcomes- sexual function
Timepoint [4] 0 0
0-24 months post radiotherapy
Secondary outcome [5] 0 0
Patient reported outcomes- chronic gastrointestinal symptoms
Timepoint [5] 0 0
0-24 months post radiotherapy
Secondary outcome [6] 0 0
Patient reported outcomes- health status
Timepoint [6] 0 0
0-24 months post radiotherapy
Secondary outcome [7] 0 0
Loco-regional MIBC control
Timepoint [7] 0 0
0-5 years post radiotherapy
Secondary outcome [8] 0 0
Progression free survival
Timepoint [8] 0 0
0-5 years post radiotherapy
Secondary outcome [9] 0 0
Overall survival
Timepoint [9] 0 0
0-5 years post radiotherapy

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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2029
Actual
Sample size
Target
Accrual to date
Final
345
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Townsville General Hospital - Douglas
Recruitment hospital [4] 0 0
Radiation Oncology Mater Centre QLD - South Brisbane
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 0 0
Austin Hospital - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Wagga Wagga
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Douglas
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Devon
Country [5] 0 0
United Kingdom
State/province [5] 0 0
England
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Essex
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Middlesex
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Scotland
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Adstone
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Belfast
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Birmingham
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Bradford
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Brighton
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Brixton
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Bury St Edmunds
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridge
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Cardiff
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Cheltenham
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Coventry
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Edinburgh
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Exeter
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Glasgow
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Guildford
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Leeds
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Newcastle upon Tyne
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Norwich
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Oldham
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Peterborough
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Portsmouth
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Preston
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Sheffield
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Sutton-in-Ashfield
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Taunton
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Wakefield
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Other
Name
Institute of Cancer Research, United Kingdom
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Trans Tasman Radiation Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02447549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Huddart
Address 0 0
Institute of Cancer Research/RMNHSFT
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries