Adaptive Planning in Bladder Cancer

NIHR

clinical trial Surrey,uk clinical research

Primary Trial ID Number

NCT01000129

Summary
To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater accuracy using a new planning method and that this method can be used simply and effectively by those delivering treatment.
Research Details
This study integrates a novel adaptive planning methodology, Adaptive-Planning Organ LOcalisation (A-POLO), with optimised margins and cone beam CT technology for improving the accuracy of radiotherapy treatment delivery. The previous study (CCR2873, REC 07/Q0801/13) evaluated the use of cone beam CT in radiotherapy for bladder cancer. A larger than expected number of bladder radiotherapy treatments were seen to have been delivered with some element of geographic miss. Using the novel adaptive planning method these fractions of radiotherapy could have been correctly treated. The feasibility of this method has been proven in the previous study, particularly it has been shown that this method is appropriate and provides a simple solution to the problem. It can be carried out by the radiographers at the treatment unit without adding extra time to the treatment.
Phase
Phase 2
Study Design
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Other : Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan), Other : Cone beam CT acquisition
Study Arm Groups : ,

Intervention Type
See Interventions above
Primary Outcome Measures
Assessment performed online at the treatment unit & verified offline by additional observer. Primary endpoint is met if there is greater than 75% concordance between the assessment made online & offline.; null
Secondary Outcome Measures
Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website

Gender
Both
Age Range
18 Years – N/A
Who Can Participate
Patients
Number of Participants
32
Participant Inclusion Criteria
Inclusion Criteria:
– Age > 18
– Histologically confirmed invasive carcinoma of the bladder
– Patient planned to receive hypofractionated radiotherapy to the bladder.
– No previous pelvic radiotherapy
– Written informed consent given according to ICH/GCP and national/local regulations.
Exclusion Criteria:
– Urinary catheter in situ: the presence of a urinary catheter degrades cone beam image
quality and thus images would not be evaluable. Patients with a urinary catheter
would not be expected to show variation in bladder filling.
Participant Exclusion Criteria
This is in the inclusion criteria above

Trial Location(s)
Research Site
Sutton
Surrey
SM2 5PT
Trial Contact(s)
Primary Trial Contact
Dr Robert Huddart
robert.huddart@icr.ac.uk
02086613457
Other Trial Contacts
Bernadette Johnson
bernadette.johnson@rmh.nhs.uk
02086613434
Countries Recruiting
United Kingdom

Scientific Title
Adaptive – Predictive Planning for Hypofractionated Bladder Radiotherapy
EudraCT Number
Not available for this trial
Funder(s)
Institute of Cancer Research, United Kingdom
Other Study ID Numbers
CCR3122
Sponsor(s)
Royal Marsden NHS Foundation Trust

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=29006 →