Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)

August 9, 2016 updated by: Institute of Cancer Research, United Kingdom

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Cardiff, United Kingdom
        • Velindre Cancer Centre
      • Ipswich, United Kingdom
        • Ipswich Hospital
      • Leeds, United Kingdom
        • St James's University Hospital
      • London, United Kingdom
        • University College London
      • London, United Kingdom
        • Royal Marsden NHSFT
      • London, United Kingdom
        • Guy's & St Thomas's Hospital
      • Norwich, United Kingdom
        • Norfolk & Norwich University Hospitals NHS Foundation Trust
      • Preston, United Kingdom
        • Royal Preston Hospital
      • Romford, United Kingdom
        • Queens Hospital
      • Wirral, United Kingdom
        • Clatterbridge Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard planning
Standard planning radiotherapy
Radiation: Standard planning radiotherapy
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
Experimental: Adaptive planning
Adaptive planning radiotherapy
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.
Time Frame: 12 weeks from start of radiotherapy
Acute CTC non-genitourinary toxicity grade 3 or higher.
12 weeks from start of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: 3 months
Presence of cancer in the bladder 3 months after treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Cancer Research UK

Investigators

  • Principal Investigator: Robert Huddart, Institute of Cancer Research/RMNHSFT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3973
  • CRUK/12/055 (Other Grant/Funding Number: CRUK)
  • ICR-CTSU/2013/10039 (Other Identifier: ICR-CTSU Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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