A multicentre randomised phase II study of hypofractionated bladder radiotherapy with or without image guided adaptive planning
| ISRCTN | ISRCTN18815596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18815596 |
| ClinicalTrials.gov number | NCT01810757 |
| Secondary identifying numbers | 15216 |
- Submission date
- 11/09/2013
- Registration date
- 11/09/2013
- Last edited
- 05/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr HYBRID Trial
Scientific
Scientific
Section of Clinical Trials
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 20 7352 8133 |
|---|---|
| HYBRID-icrctsu@icr.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A multicentre randomised phase II study of HYpofractionated Bladder Radiotherapy with or without Image guided aDaptive planning |
| Study acronym | HYBRID |
| Study objectives | 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(s) | 11/09/2013, ref: 13/LO/1350 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2013 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 62; UK Sample Size: 62; Final enrolment: 65 |
| Total final enrolment | 65 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 15/04/2015 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Clinical Trials, 15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Research organisation
Research organisation
Experimental Cancer Medicine Centre Network
Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom
"ROR" |
https://ror.org/043jzw605 |
|---|
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | 12/02/2021 | No | Yes | ||
| Protocol article | 26/05/2020 | 20/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | results | 11/12/2020 | 05/07/2023 | Yes | No |
Editorial Notes
05/07/2023: Publication reference and total final enrolment added.
20/06/2022: Publication reference added.
12/02/2021: Cancer Research UK lay results summary link added to Results (plain English).
21/01/2019: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 30/11/2014 to 31/12/2020
2. The recruitment start date has been changed from 01/12/2013 to 15/04/2015
3. The recruitment end date has been changed from 30/11/2014 to 31/08/2016
4. The total final enrolment has been added
5. The intention to publish date has been added
07/03/2017: No publications found in PubMed, verifying study status with principal investigator
