Study of Tumour Focused Radiotherapy for Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Radiation: DARTRadiation: WBRTRadiation: SART
- Registration Number
- NCT02447549
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- 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
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.
- Detailed Description
RAIDER has a two stage design. Stage 1 will establish the feasibility of delivering DART in a multi-centre setting, and stage 2 will establish the toxicity of DART. 72 patients will be recruited in stage 1, with at least an additional 168 patients in stage 2 (sufficient to recruit 57 evaluable participants to the DART group in each fractionation cohort).
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 345
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DART DART Dose escalated Adaptive tumour boost radiotherapy (DART) WBRT WBRT Standard dose whole bladder radiotherapy SART SART Standard dose Adaptive tumour focused radiotherapy (SART)
- Primary Outcome Measures
Name Time Method Proportion of participants meeting predefined radiotherapy dose constraints in DART group 4-6 weeks from randomisation Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.
Proportion of patients experiencing severe late side effects following radiotherapy. 6-18 months post radiotherapy Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.
- Secondary Outcome Measures
Name Time Method Patient reported outcomes- urinary side effects 0-24 months post radiotherapy King's Health Questionnaire (KHQ)
Patient reported outcomes- chronic gastrointestinal symptoms 0-24 months post radiotherapy Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire
Patient reported outcomes- health status 0-24 months post radiotherapy EQ-5D questionnaire
Clinician reported acute toxicity 0-6 months post radiotherapy CTCAE v4
Patient reported outcomes- symptomatic toxicity 0-24 months post radiotherapy Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire
Loco-regional MIBC control 0-5 years post radiotherapy Control of existing MIBC
Overall survival 0-5 years post radiotherapy Death from any cause
Progression free survival 0-5 years post radiotherapy Freedom from progressive disease
Patient reported outcomes- sexual function 0-24 months post radiotherapy excerpt of the EORTC QLQ-BLM30 questionnaire
Trial Locations
- Locations (49)
Maidstone Hospital, Kent Oncology Centre
🇬🇧Adstone, United Kingdom
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
Auckland Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Torbay District General Hospital
🇬🇧Torquay, Devon, United Kingdom
Ayr Hospital
🇬🇧Ayr, Scotland, 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
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
🇬🇧Romford, Essex, United Kingdom
Riverina Cancer Care Centre
🇦🇺Wagga Wagga, New South Wales, Australia
Waikato
🇳🇿Hamilton, New Zealand
The Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
Mount Vernon Cancer Centre
🇬🇧Northwood, Middlesex, 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
Belfast City Hospital
🇬🇧Belfast, 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
Cheltenham General Hospital
🇬🇧Cheltenham, 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
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
Royal Marsden NHSFT
🇬🇧London, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Guy's and St Thomas' Hospital
🇬🇧London, United Kingdom
Northern Centre for Cancer Care, Freeman Hospital,
🇬🇧Newcastle upon Tyne, United Kingdom
Royal Oldham Hospital
🇬🇧Manchester, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, 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
Mid Yorkshire Hospitals
🇬🇧Wakefield, United Kingdom
Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
Pinderfields hospital, The Mid Yorkshire Hospitals NHS Trust
🇬🇧Wakefield, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Wirral, United Kingdom