Study of Weekly Radiotherapy for Bladder Cancer

Bladder Cancer Clinical Trial

— HYBRID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01810757
• Other study ID #: CCR3973
• Secondary ID: CRUK/12/055ICR-C
• Status: Active, not recruiting
• Phase: N/A
• First received: March 8, 2013
• Last updated: August 9, 2016
• Start date: April 2014
• Est. completion date: January 2025

Study information

• Verified date: August 2016
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: January 2025
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.	Acute CTC non-genitourinary toxicity grade 3 or higher.	12 weeks from start of radiotherapy	Yes
Secondary	Local control	Presence of cancer in the bladder 3 months after treatment	3 months	No