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Trial Title:
Study of Weekly Radiotherapy for Bladder Cancer
NCT ID:
NCT01810757
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Standard planning radiotherapy
Description:
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Arm group label:
Standard planning
Intervention type:
Radiation
Intervention name:
Adaptive planning radiotherapy
Description:
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from
three plans per patient.
Arm group label:
Adaptive planning
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Country:
United Kingdom
Facility:
Name:
Velindre Cancer Centre
Address:
City:
Cardiff
Country:
United Kingdom
Facility:
Name:
Ipswich Hospital
Address:
City:
Ipswich
Country:
United Kingdom
Facility:
Name:
St James's University Hospital
Address:
City:
Leeds
Country:
United Kingdom
Facility:
Name:
Guy's & St Thomas's Hospital
Address:
City:
London
Country:
United Kingdom
Facility:
Name:
Royal Marsden NHSFT
Address:
City:
London
Country:
United Kingdom
Facility:
Name:
University College London
Address:
City:
London
Country:
United Kingdom
Facility:
Name:
Norfolk & Norwich University Hospitals NHS Foundation Trust
Address:
City:
Norwich
Country:
United Kingdom
Facility:
Name:
Royal Preston Hospital
Address:
City:
Preston
Country:
United Kingdom
Facility:
Name:
Queens Hospital
Address:
City:
Romford
Country:
United Kingdom
Facility:
Name:
Clatterbridge Cancer Centre
Address:
City:
Wirral
Country:
United Kingdom
Start date:
April 2014
Completion date:
January 2025
Lead sponsor:
Agency:
Institute of Cancer Research, United Kingdom
Agency class:
Other
Collaborator:
Agency:
Cancer Research UK
Agency class:
Other
Source:
Institute of Cancer Research, United Kingdom
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01810757