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 (NCT) | NCT01810757 |
| Protocol serial number | 15216 |
| Sponsor | Institute of Cancer Research (UK) |
| Funder | Cancer Research UK (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Proportion of patients experiencing severe acute non-genitourinary side effects after radiotherapy; Timepoint(s): Up to 3 months |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 62 |
| 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
- United Kingdom
- England
Study participating centre
Section of Clinical Trials, 15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/12/2020 | 05/07/2023 | Yes | No |
| Protocol article | 26/05/2020 | 20/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 12/02/2021 | No | Yes |
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
