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Adaptive Planning in Bladder Cancer (APPLY)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
Institute of Cancer Research, United Kingdom
Information provided by:
Royal Marsden NHS Foundation Trust Identifier:
First received: October 16, 2009
Last updated: October 21, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Bladder Cancer
Other: Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)
Other: Cone beam CT acquisition
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy

Resource links provided by NLM:

Further study details as provided by Royal Marsden NHS Foundation Trust:

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.

Estimated Enrollment: 32
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01000129

Contact: Dr Robert Huddart 02086613457
Contact: Bernadette Johnson 02086613434

United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Principal Investigator: Dr Robert Huddart         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Principal Investigator: Dr Robert Huddart Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Dr. Robert Huddart, Royal Marsden NHS Foundation Trust Identifier: NCT01000129     History of Changes
Other Study ID Numbers: CCR3122
Study First Received: October 16, 2009
Last Updated: October 21, 2009

Keywords provided by Royal Marsden NHS Foundation Trust:
Bladder cancer
Adaptive planning

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases processed this record on April 28, 2017