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
+44 20 7352 8133
HYBRID-icrctsu@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01810757
Protocol/serial number
15216
Study information
Scientific title
A multicentre randomised phase II study of HYpofractionated Bladder Radiotherapy with or without Image guided aDaptive planning
Acronym
HYBRID
Study hypothesis
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).
Ethics approval
11/09/2013, ref: 13/LO/1350
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
Participants will be randomly allocated between weekly radiotherapy and weekly adaptive radiotherapy. Both groups will receive the same radiotherapy dose.
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.
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.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list