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
- Diseases
- Bladder cancer, Childhood cancers
- 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
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Townsville General Hospital Coordinator of this site? Confirm its status | Douglas | Australia | Unknown status |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Radiation Oncology Mater Centre QLD Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Riverina Cancer Care Centre Coordinator of this site? Confirm its status | Wagga Wagga | Australia | Unknown status |
| Maidstone Hospital, Kent Oncology Centre Coordinator of this site? Confirm its status | Adstone | United Kingdom | Unknown status |
| Ayr Hospital Coordinator of this site? Confirm its status | Ayr | United Kingdom | Unknown status |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Bradford Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Bristol Haematology & Oncology Centre Coordinator of this site? Confirm its status | Brixton | United Kingdom | Unknown status |
| West Suffolk Hospital Coordinator of this site? Confirm its status | Bury St Edmunds | United Kingdom | Unknown status |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Velindre Hospital, Cardiff and Vale NHS Trust Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Cheltenham General Hospital Coordinator of this site? Confirm its status | Cheltenham | United Kingdom | Unknown status |
| University Hospital Coventry Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Royal Devon and Exeter Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Beatson West of Scotland Cancer Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| St Luke's Cancer Centre Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Marsden NHSFT Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Oldham Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Clatterbridge Cancer Centre NHS Foundation Trust Coordinator of this site? Confirm its status | Metropolitan Borough of Wirral | United Kingdom | Unknown status |
| Northern Centre for Cancer Care, Freeman Hospital, Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Mount Vernon Cancer Centre Coordinator of this site? Confirm its status | Northwood | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| Nottingham University Hospital NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| The Royal Oldham Hospital Coordinator of this site? Confirm its status | Oldham | United Kingdom | Unknown status |
| Peterborough City Hospital Coordinator of this site? Confirm its status | Peterborough | United Kingdom | Unknown status |
| Queen Alexandra Hospital Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Unknown status |
| Royal Preston Hospital Coordinator of this site? Confirm its status | Preston | United Kingdom | Unknown status |
| Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust Coordinator of this site? Confirm its status | Romford | United Kingdom | Unknown status |
| Weston Park Hospital, Sheffield Teaching Hospitals Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Kings Mill Hospital, Sherwood Forest Hospitals Foundation NHS Trust Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Unknown status |
| Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust Coordinator of this site? Confirm its status | Taunton | United Kingdom | Unknown status |
| Torbay District General Hospital Coordinator of this site? Confirm its status | Torquay | United Kingdom | Unknown status |
| Mid Yorkshire Hospitals Coordinator of this site? Confirm its status | Wakefield | United Kingdom | Unknown status |
| Pinderfields hospital, The Mid Yorkshire Hospitals NHS Trust Coordinator of this site? Confirm its status | Wakefield | United Kingdom | Unknown status |
| Auckland Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Waikato Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.