Study of Tumour Focused Radiotherapy for Bladder Cancer
RAIDER
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
1 other identifier
interventional
345
3 countries
49
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
Longer than P75 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
ExpectedJune 9, 2020
June 1, 2020
6.1 years
May 11, 2015
June 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of participants meeting predefined radiotherapy dose constraints in DART group
Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.
4-6 weeks from randomisation
Proportion of patients experiencing severe late side effects following radiotherapy.
Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.
6-18 months post radiotherapy
Secondary Outcomes (9)
Clinician reported acute toxicity
0-6 months post radiotherapy
Patient reported outcomes- symptomatic toxicity
0-24 months post radiotherapy
Patient reported outcomes- urinary side effects
0-24 months post radiotherapy
Patient reported outcomes- sexual function
0-24 months post radiotherapy
Patient reported outcomes- chronic gastrointestinal symptoms
0-24 months post radiotherapy
- +4 more secondary outcomes
Study Arms (3)
WBRT
ACTIVE COMPARATORStandard dose whole bladder radiotherapy
SART
EXPERIMENTALStandard dose Adaptive tumour focused radiotherapy (SART)
DART
EXPERIMENTALDose escalated Adaptive tumour boost radiotherapy (DART)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Townsville General Hospital
Douglas, Queensland, Australia
Radiation Oncology Mater Centre QLD
South Brisbane, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Austin Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Waikato
Hamilton, New Zealand
Torbay District General Hospital
Torquay, Devon, United Kingdom
Barts Health NHS Trust
London, England, EC1M 6BQ, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, M20 4BX, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, England, NG5 1PB, United Kingdom
Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
Romford, Essex, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Ayr Hospital
Ayr, Scotland, KA6 6DX, United Kingdom
Maidstone Hospital, Kent Oncology Centre
Adstone, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
Birmingham, United Kingdom
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust
Birmingham, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Haematology & Oncology Centre
Brixton, United Kingdom
West Suffolk Hospital
Bury St Edmunds, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Hospital, Cardiff and Vale NHS Trust
Cardiff, United Kingdom
Cheltenham General Hospital
Cheltenham, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St Luke's Cancer Centre
Guildford, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Guy's and St Thomas' Hospital
London, United Kingdom
Royal Marsden NHSFT
London, United Kingdom
Royal Oldham Hospital
Manchester, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
Northern Centre for Cancer Care, Freeman Hospital,
Newcastle upon Tyne, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
The Royal Oldham Hospital
Oldham, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Weston Park Hospital, Sheffield Teaching Hospitals Trust
Sheffield, United Kingdom
Kings Mill Hospital, Sherwood Forest Hospitals Foundation NHS Trust
Sutton in Ashfield, United Kingdom
Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust
Taunton, United Kingdom
Mid Yorkshire Hospitals
Wakefield, United Kingdom
Pinderfields hospital, The Mid Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
Related Publications (5)
Hafeez S, Warren-Oseni K, Jones K, Mohammed K, El-Ghzal A, Dearnaley D, Harris V, Khan A, Kumar P, Lalondrelle S, McDonald F, Tan M, Thomas K, Thompson A, McNair HA, Hansen VN, Huddart RA. Bladder Tumor-Focused Adaptive Radiation Therapy: Clinical Outcomes of a Phase I Dose Escalation Study. Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):165-175. doi: 10.1016/j.ijrobp.2024.07.2317. Epub 2024 Jul 26.
PMID: 39069239DERIVEDHuddart R, Hafeez S, Omar A, Alonzi R, Birtle A, Cheung KC, Choudhury A, Foroudi F, Gribble H, Henry A, Hilman S, Hindson B, Lewis R, Muthukumar D, McLaren DB, McNair H, Nikapota A, Olorunfemi A, Parikh O, Philipps L, Rimmer Y, Syndikus I, Tolentino A, Varughese M, Vassallo-Bonner C, Webster A, Griffin C, Hall E. Acute Toxicity of Hypofractionated and Conventionally Fractionated (Chemo)Radiotherapy Regimens for Bladder Cancer: An Exploratory Analysis from the RAIDER Trial. Clin Oncol (R Coll Radiol). 2023 Sep;35(9):586-597. doi: 10.1016/j.clon.2023.05.002. Epub 2023 May 9.
PMID: 37225552DERIVEDHafeez 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.
PMID: 33766502DERIVEDHafeez 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.
PMID: 33384390DERIVEDHafeez 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.
PMID: 32762980DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Huddart
Institute of Cancer Research/RMNHSFT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 19, 2015
Study Start
October 21, 2015
Primary Completion
December 1, 2021
Study Completion (Estimated)
March 1, 2029
Last Updated
June 9, 2020
Record last verified: 2020-06