Contact information
Type
Public
Contact name
Ms Hannah Gribble
ORCID ID
Contact details
ICR-CTSU
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
+44 (0)20 8722 4613
RAIDER-icrctsu@icr.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT02447549
Protocol/serial number
18868
Study information
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 (RAIDER)
Acronym
RAIDER
Study hypothesis
1. Stage I of the study aims to establish the feasibility of Dose escalated Adaptive tumour boost RT in a multi-centre setting
2. Stage II of the study aims to establish the toxicity of Dose escalated Adaptive tumour boost RT
Ethics approval(s)
London - Surrey Borders Research Ethics Committee, 22/05/2015, ref: 15/LO/0539
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Bladder cancer
Intervention
Participants are randomly allocated to one of three three groups for a course of radiotherapy:
Group 1: Participants receive standard whole bladder radiotherapy (WBRT)
Group 2: Participants receive standard dose adaptive tumour focused radiotherapy (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.
Group 3: Participants receive dose escalated adaptive tumour boost radiotherapy (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 type
Procedure/Surgery
Primary outcome measure
Feasibility and safety of the treatment is determined at the end of the treatment period
Secondary outcome measures
Ability to deliver SART and DART is determined at the end of the treatment period
Overall study start date
23/09/2015
Overall study end date
31/03/2029
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Written informed consent
2. Aged 16 years or over
3. Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder
4. Unifocal bladder TCC staged T2-T4a N0 M0
5. Fit to receive a radical course of radiotherapy
6. WHO performance status 0-2
7. Willing and able to comply with study procedures and follow up schedule
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 240; UK Sample Size: 180
Participant exclusion criteria
Current exclusion criteria as of 09/10/2018:
1. Nodal or metastatic disease
2. Multifocal invasive disease
3. Simultaneous TCC in upper tract or urethra
4. Pregnancy
5. 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)
6. Bilateral Hip replacements
7. 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)
Previous exclusion criteria:
1. Nodal or metastatic disease
2. Widespread carcinoma in situ (CIS) or CIS remote from muscle invasive tumour or multifocal invasive disease
3. Simultaneous TCC in upper tract or urethra
4. Pregnancy
5. 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)
6. 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)
Recruitment start date
23/09/2015
Recruitment end date
31/03/2020
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
The Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
Sponsor information
Organisation
The Institute of Cancer Research
Sponsor details
Clinical Magnetic Resonance
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
+44 (0)20 8722 4643
registry@icr.ac.uk
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |