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Study of Weekly Radiotherapy for Bladder Cancer

Information source: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bladder Cancer

Intervention: Standard planning radiotherapy (Radiation); Adaptive planning radiotherapy (Radiation)

Phase: N/A

Status: Recruiting

Sponsored by: Institute of Cancer Research, United Kingdom

Official(s) and/or principal investigator(s):
Robert Huddart, Principal Investigator, Affiliation: Institute of Cancer Research/RMNHSFT

Overall contact:
HYBRID Trial Manager, Phone: 0208 722 4081, Email: HYBRID-icrctsu@icr.ac.uk

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.

Clinical Details

Official title: A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.

Secondary outcome: Local control

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

HYBRID Trial Manager, Phone: 0208 722 4081, Email: HYBRID-icrctsu@icr.ac.uk

Addenbrooke's Hospital, Cambridge, United Kingdom; Recruiting
Yvonne Rimmer, Principal Investigator

Velindre Cancer Centre, Cardiff, United Kingdom; Recruiting
John Staffurth, Principal Investigator

Ipswich Hospital, Ipswich, United Kingdom; Recruiting
Ramachandran Venkitaraman, Principal Investigator

St James's University Hospital, Leeds, United Kingdom; Not yet recruiting
Ann Henry, Principal Investigator

Guy's & St Thomas's Hospital, London, United Kingdom; Recruiting
Simon Hughes, Principal Investigator

Royal Marsden NHSFT, London, United Kingdom; Recruiting
Robert Huddart

Royal Marsden NHSFT, London, United Kingdom; Recruiting
Vincent Khoo, Principal Investigator

University College London, London, United Kingdom; Recruiting
Anita Mitra, Principal Investigator

Royal Preston Hospital, Preston, United Kingdom; Not yet recruiting
Alison Birtle, Principal Investigator

Clatterbridge Cancer Centre, Wirral, United Kingdom; Recruiting
Isabel Syndikus, Principal Investigator

Additional Information

Starting date: April 2014
Last updated: December 3, 2014

Page last updated: August 23, 2015

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