Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
65 participants
INTERVENTIONAL
2014-04-30
2023-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
How results will be used Results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. The randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Tumour Focused Radiotherapy for Bladder Cancer
NCT02447549
Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
NCT00024349
Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation
NCT05912205
Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer (GETUG-AFU 30)
NCT03333356
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer
NCT06310369
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary To assess whether adaptive radiotherapy techniques when delivered at multiple centres can lead to a reduction in the level of acute non-genitourinary (GU) toxicity experienced by patients with muscle invasive bladder cancer unsuitable for daily radical radiotherapy.
Secondary
* Establish the local disease control rates of hypofractionated bladder radiotherapy as measured at 3 months
* Assess time to local disease progression
* Assess the overall survival time of patients who have received hypofractionated radiotherapy.
* Investigate the control rate of presenting symptoms, the effect of hypofractionated treatment on late radiotherapy side effects and patient reported outcomes.
* To establish the proportion of fractions benefiting from adaptive planning.
OUTLINE: This is a multicentre randomised Phase II study in patients with muscle invasive bladder who are not suitable for cystectomy or daily radiotherapy.
All patients will be planned to receive six 6Gray (Gy) fractions of image guided radiotherapy delivered weekly (total dose: 36Gy) and will be randomised to standard or adaptive planning.
Participants allocated to the standard planning group will have one radiotherapy plan generated and this will be used to deliver all 6 treatments, with a cone beam CT scan prior to treatment delivery which can be used by the local investigator to adjust treatment delivery according to local practice.
Participants allocated to adaptive planning will have three radiotherapy plans generated; small, medium and large. A cone beam CT taken prior to each treatment delivery will be used to select the most appropriate plan of the day.
Patients are followed up in terms of the trial up to 24 months, after this time only basic routine follow-up data will be collected.
PROJECTED ACCURAL: The aim is to recruit 62 participants, 31 to each treatment allocation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard planning
Standard planning radiotherapy
Standard planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive planning
Adaptive planning radiotherapy
Adaptive planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Adaptive planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cancer Research UK
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Huddart
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research/RMNHSFT
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Farbiszewski R, Ustymowicz J, Dudek H. [Participation of free radicals in the mechanism of brain tissue damage]. Neurol Neurochir Pol. 1993 Sep-Oct;27(5):729-37. Polish.
Hafeez 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRUK/12/055
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ICR-CTSU/2013/10039
Identifier Type: OTHER
Identifier Source: secondary_id
CCR3973
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.