Condition category
Cancer
Date applied
11/09/2013
Date assigned
11/09/2013
Last edited
15/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr HYBRID Trial

ORCID ID

Contact details

Section of Clinical Trials
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
HYBRID-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01810757

Protocol/serial number

15216

Study information

Scientific title

Acronym

HYBRID

Study hypothesis

Bladder cancer is the seventh most common cancer in the UK, with 10,324 new cases diagnosed in 2010. 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. Many patients diagnosed with muscle invasive bladder cancer find it difficult to attend hospital for daily radiotherapy, therefore HYBRID is investigating an alternative, using larger doses of radiotherapy given once a week for six weeks. This type of treatment is often offered to those who are unsuitable for daily radiotherapy, however it has not been formally tested within a prospective multicentre trial.

HYBRID aims to collect robust information about the side effects of weekly bladder radiotherapy, and is also investigating whether side effects can be reduced by using scans taken before each weekly treatment to tailor radiotherapy delivery (adaptive radiotherapy). Radiotherapy is normally delivered using a single plan throughout treatment. In adaptive radiotherapy the delivery plan is chosen from 3 possible plans. Participants will be randomly allocated between weekly radiotherapy and weekly adaptive radiotherapy. Both groups will receive the same radiotherapy dose.

Participants will visit the hospital 4 weeks, 3, 6, 12 and 24 months after radiotherapy to receive treatment for any symptoms and to check whether the cancer has returned. The main aim of HYBRID is to establish whether use of adaptive radiotherapy can reduce nonbladder side effects by reducing the amount of nonbladder tissue exposed to high doses of radiotherapy. HYBRID will also combine the results of both treatment groups to investigate how well weekly radiotherapy controls bladder cancer.

Ethics approval

13/LO/1350; First MREC approval date 11/09/2013

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Bladder Cancer; Disease: Bladder (superficial)

Intervention

1. Adaptive planning, 36 Gray of hypofractionated radiotherapy will be delivered in 6 fractions using the best fitting of 3 plans at each treatment. Plans will be selected and verified by accredited staff.
2. Standard planning (control), 36 Gray of hypofractionated radiotherapy will be delivered in 6 fractions using standard planning and delivery techniques.
Study Entry : Single Randomisation only

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Proportion of patients experiencing severe acute non-genitourinary side effects after radiotherapy; Timepoint(s): Up to 3 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2013

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Age =18 years
3. Histologically confirmed invasive bladder carcinoma (T2T4a N0 M0; any histological subtype)
4. Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, comorbidity, patient refusal)
5. Expected survival more than 6 months
6. WHO performance status 03
7. Willing to undergo post treatment cystoscopy
8. Able to attend post treatment follow up

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 62; UK Sample Size: 62

Participant exclusion criteria

1. Nodal or metastatic disease
2. Concurrent 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)
3. Previous pelvic radiotherapy
4. Urinary catheter in situ
5. Any other contraindication to radiotherapy (e.g. inflammatory bowel disease)

Recruitment start date

01/12/2013

Recruitment end date

30/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Clinical Trials, 15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

Experimental Cancer Medicine Centre Network
Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (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