AzTrials
AzTrials

Bladder CancerPhase 2RAIDERNCT02447549

Study of Tumour Focused Radiotherapy for Bladder Cancer

A Phase 2 study testing WBRT, SART and DART in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 49 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
WBRT, SART and DART
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
49 sitesin 3 countries
Study dates
21 Oct 2015to Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

49 sites in 3 countries.

49 sites in 3 countries

United Kingdom39 sites

  • Maidstone Hospital, Kent Oncology Centre

    Adstone

  • Ayr Hospital

    Ayr, Scotland, KA6 6DX

  • Belfast City Hospital

    Belfast

  • Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust

    Birmingham

  • Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust

    Birmingham

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford

  • Royal Sussex County Hospital

    Brighton

  • Bristol Haematology & Oncology Centre

    Brixton

  • West Suffolk Hospital

    Bury St Edmunds

  • Addenbrooke's Hospital

    Cambridge

  • Velindre Hospital, Cardiff and Vale NHS Trust

    Cardiff

  • Cheltenham General Hospital

    Cheltenham

  • University Hospital Coventry

    Coventry

  • Western General Hospital

    Edinburgh

  • Royal Devon and Exeter Hospital

    Exeter

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • St Luke's Cancer Centre

    Guildford

  • Leeds Teaching Hospitals NHS Trust

    Leeds

  • Barts Health NHS Trust

    London, England, EC1M 6BQ

  • Guy's and St Thomas' Hospital

    London

  • Royal Marsden NHSFT

    London

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

  • Royal Oldham Hospital

    Manchester

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral

  • Northern Centre for Cancer Care, Freeman Hospital,

    Newcastle upon Tyne

  • Mount Vernon Cancer Centre

    Northwood, Middlesex

  • Norfolk and Norwich University Hospital

    Norwich

  • Nottingham University Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • The Royal Oldham Hospital

    Oldham

  • Peterborough City Hospital

    Peterborough

  • Queen Alexandra Hospital

    Portsmouth

  • Royal Preston Hospital

    Preston

  • Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust

    Romford, Essex

  • Weston Park Hospital, Sheffield Teaching Hospitals Trust

    Sheffield

  • Kings Mill Hospital, Sherwood Forest Hospitals Foundation NHS Trust

    Sutton in Ashfield

  • Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust

    Taunton

  • Torbay District General Hospital

    Torquay, Devon

  • Mid Yorkshire Hospitals

    Wakefield

  • Pinderfields hospital, The Mid Yorkshire Hospitals NHS Trust

    Wakefield

Other trials in United Kingdom

Australia7 sites

  • Princess Alexandra Hospital

    Brisbane, Queensland

  • Townsville General Hospital

    Douglas, Queensland

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Austin Hospital

    Melbourne, Victoria

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia

  • Radiation Oncology Mater Centre QLD

    South Brisbane, Queensland

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales

Other trials in Australia

New Zealand3 sites

  • Auckland Hospital

    Auckland

  • Christchurch Hospital

    Christchurch

  • Waikato

    Hamilton

Other trials in New Zealand

About this study

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

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.

Read more

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.

Read the 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.

Conditions
Bladder Cancer
Being tested
WBRT, SART, DART
Keywords
IMRT, IGRT, Muscle invasive, Adaptive Radiotherapy
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WBRTRadiation

    One RT plan with whole bladder treated to standard dose.

  • SARTRadiation

    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.

  • DARTRadiation

    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.

Study groups in NCT02447549
Study groupRoleWhat they receive
WBRTActive comparatorStandard dose whole bladder radiotherapy
Receives: Radiation: WBRT
SARTExperimentalStandard dose Adaptive tumour focused radiotherapy (SART)
Receives: Radiation: SART
DARTExperimentalDose escalated Adaptive tumour boost radiotherapy (DART)
Receives: Radiation: DART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants meeting predefined radiotherapy dose constraints in DART group

    Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.

    Measured: 4-6 weeks from randomisation

  2. Proportion of patients experiencing severe late side effects following radiotherapy.

    Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.

    Measured: 6-18 months post radiotherapy

Secondary outcomes (9)

  1. Clinician reported acute toxicity

    CTCAE v4

    Measured: 0-6 months post radiotherapy

  2. Patient reported outcomes- symptomatic toxicity

    Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire

    Measured: 0-24 months post radiotherapy

  3. Patient reported outcomes- urinary side effects

    King's Health Questionnaire (KHQ)

    Measured: 0-24 months post radiotherapy

  4. Patient reported outcomes- sexual function

    excerpt of the EORTC QLQ-BLM30 questionnaire

    Measured: 0-24 months post radiotherapy

  5. Patient reported outcomes- chronic gastrointestinal symptoms

    Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire

    Measured: 0-24 months post radiotherapy

  6. Patient reported outcomes- health status

    EQ-5D questionnaire

    Measured: 0-24 months post radiotherapy

  7. Loco-regional MIBC control

    Control of existing MIBC

    Measured: 0-5 years post radiotherapy

  8. Progression free survival

    Freedom from progressive disease

    Measured: 0-5 years post radiotherapy

  9. Overall survival

    Death from any cause

    Measured: 0-5 years post radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study start21 Oct 2015
  3. Primary completionDec 2021 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02447549
Sponsor's protocol ID
ICR-CTSU/2014/10049
Acronym
RAIDER
Status last verified
Jun 2020
First submitted
11 May 2015
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39069239

  • 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.

    PubMed 37225552

  • 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.

    PubMed 33766502

  • 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.

    PubMed 33384390

  • 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.

    PubMed 32762980

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing WBRT, SART and DART in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 49 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants meeting predefined radiotherapy dose constraints in DART group (time frame: 4-6 weeks from randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02447549, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

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