Study of Tumour Focused Radiotherapy for Bladder Cancer
NCT ID: NCT02447549
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
345 participants
INTERVENTIONAL
2015-10-21
2029-03-31
Brief Summary
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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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Detailed Description
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Both fractionation regimens in standard use in UK are included - 32f and 20f. Participants will be permitted to receive concomitant chemotherapy. Primary endpoints will be assessed in each fractionation cohort separately with the flexibility to drop either a fractionation cohort or an experimental treatment group (on advice of Independent Data Monitoring Committee) following completion of stage 1.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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WBRT
Standard dose whole bladder radiotherapy
WBRT
One RT plan with whole bladder treated to standard dose.
SART
Standard dose Adaptive tumour focused radiotherapy (SART)
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.
DART
Dose escalated Adaptive tumour boost radiotherapy (DART)
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.
Interventions
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WBRT
One RT plan with whole bladder treated to standard dose.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
16 Years
ALL
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Robert Huddart
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research/RMNHSFT
Locations
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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, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, England, 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, 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
Countries
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References
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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.
Huddart 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.
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.
Other Identifiers
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ICR-CTSU/2014/10049
Identifier Type: -
Identifier Source: org_study_id
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