Adaptive Planning in Bladder Cancer (APPLY)
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)
Cone beam CT acquisition
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Radiotherapy, Bladder cancer, Adaptive planning
Eligibility 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.
Sites / Locations
- Royal Marsden NHS Foundation TrustRecruiting
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01000129
First Posted
October 16, 2009
Last Updated
October 21, 2009
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Institute of Cancer Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01000129
Brief Title
Adaptive Planning in Bladder Cancer
Acronym
APPLY
Official Title
Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Institute of Cancer Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Radiotherapy, Bladder cancer, Adaptive planning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)
Intervention Description
Planning CT scan performed by qualified planning radiographers
Intervention Type
Other
Intervention Name(s)
Cone beam CT acquisition
Intervention Description
Cone beam CT acquisition performed by therapy radiographers who have training and experience of using cone beam CT.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Robert Huddart
Phone
02086613457
Email
robert.huddart@icr.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Bernadette Johnson
Phone
02086613434
Email
bernadette.johnson@rmh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Robert Huddart
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Robert Huddart
12. IPD Sharing Statement
Learn more about this trial
Adaptive Planning in Bladder Cancer
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