Study of tumour focused radiotherapy for bladder cancer

ISRCTN	ISRCTN26779187
DOI	https://doi.org/10.1186/ISRCTN26779187
ClinicalTrials.gov number	NCT02447549
Secondary identifying numbers	18868

Submission date: 14/10/2015
Registration date: 14/10/2015
Last edited: 13/12/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-different-ways-of-giving-radiotherapy-for-bladder-cancer-raider

Study website

Contact information

Ms Hannah Gribble
Public

ICR-CTSU
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Phone	+44 (0)20 8722 4613
Email	RAIDER-icrctsu@icr.ac.uk

Study information

Study design	Randomized; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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)
Study acronym	RAIDER
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	31/03/2029

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target number of participants	Planned Sample Size: 240; UK Sample Size: 180
Total final enrolment	345
Key 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
Key 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)
Date of first enrolment	23/09/2015
Date of final enrolment	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

The Institute of Cancer Research
Research organisation

Clinical Magnetic Resonance
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Phone	+44 (0)20 8722 4643
Email	registry@icr.ac.uk
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, Cancer Research UK (CRUK), CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary		28/06/2023	No	No
Results article	24/09/2024	11/10/2024	Yes	No
Plain English results		13/12/2024	No	Yes

Editorial Notes

13/12/2024: Cancer Research UK plain English results added.
11/10/2024: Publication reference and total final enrolment added.
20/09/2021: Internal review.
30/04/2020: Contact details updated.
27/01/2020: The recruitment end date has been changed from 31/12/2019 to 31/03/2020.
16/08/2019: The recruitment end date was changed from 31/07/2019 to 31/12/2019.
02/04/2019: The condition has been changed from "Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (advanced)" to "Bladder cancer" following a request from the NIHR.
09/10/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2018 to 31/07/2019.
2. The exclusion criteria were updated.
26/01/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2018 to 31/08/2018.
2. The overall trial end date was changed from 01/03/2018 to 31/03/2029.
12/10/2017: Contact name updated.
27/01/2016: Plain English summary link added.