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ACTIVE NOT RECRUITING
NCT02447549
PHASE2

Study of Tumour Focused Radiotherapy for Bladder Cancer

Sponsor: Institute of Cancer Research, United Kingdom

View on ClinicalTrials.gov

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 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.

Official 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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

345

Start Date

2015-10-21

Completion Date

2029-03

Last Updated

2020-06-09

Healthy Volunteers

No

Conditions

Interventions

RADIATION

WBRT

One RT plan with whole bladder treated to standard dose.

RADIATION

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.

RADIATION

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.

Locations (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, 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