Adaptive Planning in Bladder Cancer (APPLY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000129
Recruitment Status : Unknown
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : October 22, 2009
Last Update Posted : October 22, 2009
Institute of Cancer Research, United Kingdom
Information provided by:
Royal Marsden NHS Foundation Trust

October 16, 2009
October 22, 2009
October 22, 2009
January 2009
December 2010   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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Adaptive Planning in Bladder Cancer
Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy
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.

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 2
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Bladder Cancer
  • Other: Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)
    Planning CT scan performed by qualified planning radiographers
  • Other: Cone beam CT acquisition
    Cone beam CT acquisition performed by therapy radiographers who have training and experience of using cone beam CT.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Dr. Robert Huddart, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Principal Investigator: Dr Robert Huddart Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP