Study of Tumour Focused Radiotherapy for Bladder Cancer (RAIDER)

June 5, 2020 updated by: Institute of Cancer Research, United Kingdom

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wagga Wagga, New South Wales, Australia
        • Riverina Cancer Care Centre
    • Queensland
      • Brisbane, Queensland, Australia
        • Princess Alexandra Hospital
      • Douglas, Queensland, Australia
        • Townsville General Hospital
      • South Brisbane, Queensland, Australia
        • Radiation Oncology Mater Centre QLD
    • Tasmania
      • Hobart, Tasmania, Australia
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • Austin Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Sir Charles Gairdner Hospital
  • New Zealand
      • Auckland, New Zealand
        • Auckland Hospital
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Hamilton, New Zealand
        • Waikato
  • United Kingdom
      • Adstone, United Kingdom
        • Maidstone Hospital, Kent Oncology Centre
      • Belfast, United Kingdom
        • Belfast City Hospital
      • Birmingham, United Kingdom
        • Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust
      • Bradford, United Kingdom
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • Brixton, United Kingdom
        • Bristol Haematology & Oncology Centre
      • Bury St Edmunds, United Kingdom
        • West Suffolk Hospital
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Cardiff, United Kingdom
        • Velindre Hospital, Cardiff and Vale NHS Trust
      • Cheltenham, United Kingdom
        • Cheltenham General Hospital
      • Coventry, United Kingdom
        • University Hospital Coventry
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Exeter, United Kingdom
        • Royal Devon and Exeter Hospital
      • Glasgow, United Kingdom
        • Beatson West Of Scotland Cancer Centre
      • Guildford, United Kingdom
        • St Luke's Cancer Centre
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom
        • Guy's and St Thomas' Hospital
      • London, United Kingdom
        • Royal Marsden NHSFT
      • Manchester, United Kingdom
        • Royal Oldham Hospital
      • Newcastle upon Tyne, United Kingdom
        • Northern Centre for Cancer Care, Freeman Hospital,
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospital
      • Oldham, United Kingdom
        • The Royal Oldham Hospital
      • Peterborough, United Kingdom
        • Peterborough City Hospital
      • Portsmouth, United Kingdom
        • Queen Alexandra Hospital
      • Preston, United Kingdom
        • Royal Preston Hospital
      • Sheffield, United Kingdom
        • Weston Park Hospital, Sheffield Teaching Hospitals Trust
      • Sutton-in-Ashfield, United Kingdom
        • Kings Mill Hospital, Sherwood Forest Hospitals Foundation NHS Trust
      • Taunton, United Kingdom
        • Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust
      • Wakefield, United Kingdom
        • Mid Yorkshire Hospitals
      • Wakefield, United Kingdom
        • Pinderfields hospital, The Mid Yorkshire Hospitals NHS Trust
      • Wirral, United Kingdom
        • The Clatterbridge Cancer Centre NHS Foundation Trust
    • Devon
      • Torquay, Devon, United Kingdom
        • Torbay District General Hospital
    • England
      • London, England, United Kingdom, EC1M 6BQ
        • Barts Health NHS Trust
      • Manchester, England, United Kingdom, M20 4BX
        • The Christie Nhs Foundation Trust
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham University Hospital NHS Trust
    • Essex
      • Romford, Essex, United Kingdom
        • Queen's Hospital, Barking Havering and Redbridge University Hospitals NHS Trust
    • Middlesex
      • Northwood, Middlesex, United Kingdom
        • Mount Vernon Cancer Centre
    • Scotland
      • Ayr, Scotland, United Kingdom, KA6 6DX
        • Ayr Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: WBRT
Standard dose whole bladder radiotherapy
Radiation: WBRT
One RT plan with whole bladder treated to standard dose.
Experimental: SART
Standard dose Adaptive tumour focused radiotherapy (SART)
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.
Experimental: DART
Dose escalated Adaptive tumour boost radiotherapy (DART)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants meeting predefined radiotherapy dose constraints in DART group
Time Frame: 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.
4-6 weeks from randomisation
Proportion of patients experiencing severe late side effects following radiotherapy.
Time Frame: 6-18 months post radiotherapy
Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.
6-18 months post radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician reported acute toxicity
Time Frame: 0-6 months post radiotherapy
CTCAE v4
0-6 months post radiotherapy
Patient reported outcomes- symptomatic toxicity
Time Frame: 0-24 months post radiotherapy
Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire
0-24 months post radiotherapy
Patient reported outcomes- urinary side effects
Time Frame: 0-24 months post radiotherapy
King's Health Questionnaire (KHQ)
0-24 months post radiotherapy
Patient reported outcomes- sexual function
Time Frame: 0-24 months post radiotherapy
excerpt of the EORTC QLQ-BLM30 questionnaire
0-24 months post radiotherapy
Patient reported outcomes- chronic gastrointestinal symptoms
Time Frame: 0-24 months post radiotherapy
Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire
0-24 months post radiotherapy
Patient reported outcomes- health status
Time Frame: 0-24 months post radiotherapy
EQ-5D questionnaire
0-24 months post radiotherapy
Loco-regional MIBC control
Time Frame: 0-5 years post radiotherapy
Control of existing MIBC
0-5 years post radiotherapy
Progression free survival
Time Frame: 0-5 years post radiotherapy
Freedom from progressive disease
0-5 years post radiotherapy
Overall survival
Time Frame: 0-5 years post radiotherapy
Death from any cause
0-5 years post radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Trans Tasman Radiation Oncology Group

Investigators

  • Principal Investigator: Robert Huddart, Institute of Cancer Research/RMNHSFT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 5, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICR-CTSU/2014/10049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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