Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatments standard planning radiotherapy, adaptive planning radiotherapy
Sponsor Institute of Cancer Research, United Kingdom
Collaborator Cancer Research UK
Start date April 2014
End date July 2017
Trial size 64 participants
Trial identifier NCT01810757, CCR3973, CRUK/12/055, ICR-CTSU/2013/10039

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Standard planning radiotherapy
standard planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
(Experimental)
Adaptive planning radiotherapy
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.

Primary Outcomes

Measure
Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.
time frame: 12 weeks from start of radiotherapy

Secondary Outcomes

Measure
Local control
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning
Principal investigator Robert Huddart
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Institute of Cancer Research, United Kingdom.