Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01810757 |
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Recruitment Status :
Active, not recruiting
First Posted : March 14, 2013
Last Update Posted : August 10, 2016
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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:
- whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity
- the local tumour control rate achieved by hypofractionated weekly radiotherapy
- 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer | Radiation: Standard planning radiotherapy Radiation: Adaptive planning radiotherapy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning |
| Study Start Date : | April 2014 |
| Estimated Primary Completion Date : | July 2017 |
| Estimated Study Completion Date : | January 2025 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard planning
Standard planning radiotherapy
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Radiation: Standard planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient. |
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Experimental: Adaptive planning
Adaptive planning radiotherapy
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Radiation: 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. |
- Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy. [ Time Frame: 12 weeks from start of radiotherapy ]Acute CTC non-genitourinary toxicity grade 3 or higher.
- Local control [ Time Frame: 3 months ]Presence of cancer in the bladder 3 months after treatment
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810757
| United Kingdom | |
| 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 | |
| Norfolk & Norwich University Hospitals NHS Foundation Trust | |
| Norwich, United Kingdom | |
| Royal Preston Hospital | |
| Preston, United Kingdom | |
| Queens Hospital | |
| Romford, United Kingdom | |
| Clatterbridge Cancer Centre | |
| Wirral, United Kingdom | |
| Principal Investigator: | Robert Huddart | Institute of Cancer Research/RMNHSFT |
| Responsible Party: | Institute of Cancer Research, United Kingdom |
| ClinicalTrials.gov Identifier: | NCT01810757 |
| Other Study ID Numbers: |
CCR3973 CRUK/12/055 ( Other Grant/Funding Number: CRUK ) ICR-CTSU/2013/10039 ( Other Identifier: ICR-CTSU Protocol Number ) |
| First Posted: | March 14, 2013 Key Record Dates |
| Last Update Posted: | August 10, 2016 |
| Last Verified: | August 2016 |
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Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |