Clinical trial NCT01810757: Study of Weekly Radiotherapy for Bladder Cancer
Official title: A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2013-03-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.


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

Primary outcomes:
measure: Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.
timeFrame: 12 weeks from start of radiotherapy
Secondary outcomes:
measure: Local control
timeFrame: 3 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: Guy's & St Thomas's Hospital
city: London
country: United Kingdom
facility: Royal Marsden NHSFT
city: London
country: United Kingdom
facility: University College London
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospitals NHS Foundation Trust
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Romford
country: United Kingdom
facility: Queens Hospital
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
Study officials:
affiliation: Institute of Cancer Research/RMNHSFT
name: Robert Huddart
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.