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NCT02447549Active, not recruitingPhase 2

Study of Tumour Focused Radiotherapy for Bladder Cancer

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

Source: ClinicalTrials.gov · Last updated 9 Jun 2020

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
345 (actual)
First submitted
11 May 2015
Start date
21 Oct 2015
Primary completion date
Dec 2021
Lead sponsor
Institute of Cancer Research, United Kingdom
NCT number
NCT02447549

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 345
  • From 21 Oct 2015 to the primary completion date, Dec 2021
  • 49 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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)

Other illness

  • Nodal or metastatic disease
  • Multifocal invasive disease

Other

  • Simultaneous TCC in upper tract or urethra
  • Pregnancy
  • Bilateral hip replacements

Who the study is looking for

  • 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

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Alexandra Hospital
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BrisbaneAustraliaUnknown status
Townsville General Hospital
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DouglasAustraliaUnknown status
Royal Hobart Hospital
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HobartAustraliaUnknown status
Austin Hospital
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MelbourneAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
Radiation Oncology Mater Centre QLD
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South BrisbaneAustraliaUnknown status
Riverina Cancer Care Centre
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Wagga WaggaAustraliaUnknown status
Maidstone Hospital, Kent Oncology Centre
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AdstoneUnited KingdomUnknown status
Ayr Hospital
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AyrUnited KingdomUnknown status
Belfast City Hospital
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BelfastUnited KingdomUnknown status
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust
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BirminghamUnited KingdomUnknown status
Bradford Teaching Hospitals NHS Foundation Trust
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BradfordUnited KingdomUnknown status
Royal Sussex County Hospital
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BrightonUnited KingdomUnknown status
Bristol Haematology & Oncology Centre
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BrixtonUnited KingdomUnknown status
West Suffolk Hospital
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Bury St EdmundsUnited KingdomUnknown status
Addenbrooke's Hospital
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CambridgeUnited KingdomUnknown status
Velindre Hospital, Cardiff and Vale NHS Trust
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CardiffUnited KingdomUnknown status
Cheltenham General Hospital
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CheltenhamUnited KingdomUnknown status
University Hospital Coventry
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CoventryUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
Royal Devon and Exeter Hospital
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ExeterUnited KingdomUnknown status
Beatson West of Scotland Cancer Centre
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GlasgowUnited KingdomUnknown status
St Luke's Cancer Centre
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GuildfordUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
Royal Marsden NHSFT
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LondonUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Guy's and St Thomas' Hospital
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LondonUnited KingdomUnknown status
Royal Oldham Hospital
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ManchesterUnited KingdomUnknown status
The Christie NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
The Clatterbridge Cancer Centre NHS Foundation Trust
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Metropolitan Borough of WirralUnited KingdomUnknown status
Northern Centre for Cancer Care, Freeman Hospital,
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Newcastle upon TyneUnited KingdomUnknown status
Mount Vernon Cancer Centre
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NorthwoodUnited KingdomUnknown status
Norfolk and Norwich University Hospital
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NorwichUnited KingdomUnknown status
Nottingham University Hospital NHS Trust
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NottinghamUnited KingdomUnknown status
The Royal Oldham Hospital
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OldhamUnited KingdomUnknown status
Peterborough City Hospital
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PeterboroughUnited KingdomUnknown status
Queen Alexandra Hospital
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PortsmouthUnited KingdomUnknown status
Royal Preston Hospital
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PrestonUnited KingdomUnknown status
Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
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RomfordUnited KingdomUnknown status
Weston Park Hospital, Sheffield Teaching Hospitals Trust
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SheffieldUnited KingdomUnknown status
Kings Mill Hospital, Sherwood Forest Hospitals Foundation NHS Trust
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Sutton in AshfieldUnited KingdomUnknown status
Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust
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TauntonUnited KingdomUnknown status
Torbay District General Hospital
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TorquayUnited KingdomUnknown status
Mid Yorkshire Hospitals
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WakefieldUnited KingdomUnknown status
Pinderfields hospital, The Mid Yorkshire Hospitals NHS Trust
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WakefieldUnited KingdomUnknown status
Auckland Hospital
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AucklandNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Waikato
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HamiltonNew ZealandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.