Study of Weekly Radiotherapy for Bladder Cancer
HYBRID
A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning
3 other identifiers
interventional
65
1 country
11
Brief Summary
Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option. Radiotherapy treatment is planned based on information from a CT scan which shows the position and shape of the bladder. This plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. A safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy. It is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. In this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects. Aims In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:
- 1.whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity
- 2.the local tumour control rate achieved by hypofractionated weekly radiotherapy
- 3.the requirement to treat with adaptive planning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedResults Posted
Study results publicly available
January 15, 2026
CompletedJanuary 15, 2026
December 1, 2025
2.3 years
March 8, 2013
June 26, 2024
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Experiencing Severe Acute Non-genitourinary Side Effects Following Radiotherapy.
Non-GU CTCAE G3+ treatment-related toxicity occurring within the first 3 months of radiotherapy completing
12 weeks from completion of radiotherapy
Secondary Outcomes (5)
Local Disease Control Rate
3 months
Time to Local Disease Progression
Event-free survival estimates at 12 months and 24 months are reported.
Overall Survival
Event-free survival estimates at 12 months and 24months are reported.
The Control Rate of Presenting Symptoms
3 months from the completion of radiotherapy
The Proportion of Fractions Benefiting From Adaptive Planning
End of treatment, treatment is given over 6 weeks
Study Arms (2)
Standard planning
ACTIVE COMPARATORStandard planning radiotherapy
Adaptive planning
EXPERIMENTALAdaptive planning radiotherapy
Interventions
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Age ≥18 years
- Histologically confirmed invasive bladder carcinoma (T2-T4a N0 M0; any histological sub-type)
- Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, co-morbidity, patient refusal)
- Expected survival \>6 months
- WHO performance status 0-3
- Willing to undergo post treatment cystoscopy
You may not qualify if:
- Nodal or metastatic disease
- Concurrent malignancy
- Previous pelvic radiotherapy
- Urinary catheter in-situ
- Any other contra-indication to radiotherapy (e.g. inflammatory bowel disease)
- Unable to attend for post treatment follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Cancer Research, United Kingdomlead
- Cancer Research UKcollaborator
Study Sites (11)
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Guy's & St Thomas's Hospital
London, United Kingdom
Royal Marsden NHSFT
London, United Kingdom
University College London
London, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Queens Hospital
Romford, United Kingdom
Related Publications (2)
Huddart R, Hafeez S, Lewis R, McNair H, Syndikus I, Henry A, Staffurth J, Dewan M, Vassallo-Bonner C, Moinuddin SA, Birtle A, Horan G, Rimmer Y, Venkitaraman R, Khoo V, Mitra A, Hughes S, Gibbs S, Kapur G, Baker A, Hansen VN, Patel E, Hall E; HYBRID Investigators. Clinical Outcomes of a Randomized Trial of Adaptive Plan-of-the-Day Treatment in Patients Receiving Ultra-hypofractionated Weekly Radiation Therapy for Bladder Cancer. Int J Radiat Oncol Biol Phys. 2021 Jun 1;110(2):412-424. doi: 10.1016/j.ijrobp.2020.11.068. Epub 2020 Dec 11.
PMID: 33316362RESULTHafeez S, Patel E, Webster A, Warren-Oseni K, Hansen V, McNair H, Miles E, Lewis R, Hall E, Huddart R. Protocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance. BMJ Open. 2020 May 26;10(5):e037134. doi: 10.1136/bmjopen-2020-037134.
PMID: 32461298DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Emma Hall (Co-Director of ICR-CTSU)
- Organization
- The Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Huddart
Institute of Cancer Research/RMNHSFT
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2013
First Posted
March 14, 2013
Study Start
April 1, 2014
Primary Completion
August 1, 2016
Study Completion
April 1, 2023
Last Updated
January 15, 2026
Results First Posted
January 15, 2026
Record last verified: 2025-12