Condition category
Cancer
Date applied
14/10/2015
Date assigned
14/10/2015
Last edited
27/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr Joanna Illambas

ORCID ID

Contact details

The Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02447549

Protocol/serial number

18868

Study information

Scientific 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 (RAIDER)

Acronym

RAIDER

Study hypothesis

1. Stage I of the study aims to establish the feasibility of DART in a multi-centre setting
2. Stage II of the study aims to establish the toxicity of DART

Ethics approval

15/LO/0539

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (advanced)

Intervention

Participants are randomly allocated to one of three three groups for a course of radiotherapy:

Group 1: Participants receive standard whole bladder radiotherapy (WBRT)
Group 2: Participants receive standard dose adaptive tumour focused radiotherapy (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.
Group 3: Participants receive dose escalated adaptive tumour boost radiotherapy (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.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Feasibility and safety of the treatment is determined at the end of the treatment period.

Secondary outcome measures

Ability to deliver SART and DART is determined at the end of the treatment period.

Overall trial start date

23/09/2015

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Aged 16 years or over
3. Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder
4. Unifocal bladder TCC staged T2-T4a N0 M0
5. Fit to receive a radical course of radiotherapy
6. WHO performance status 0-2
7. Willing and able to comply with study procedures and follow up schedule

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 180

Participant exclusion criteria

1. Nodal or metastatic disease
2. Widespread carcinoma in situ (CIS) or CIS remote from muscle invasive tumour or multifocal invasive disease
3. Simultaneous TCC in upper tract or urethra
4. Pregnancy
5. 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)
6. 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)

Recruitment start date

23/09/2015

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

The Institute of Cancer Research

Sponsor details

Clinical Magnetic Resonance
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/01/2016: Plain English summary link added.