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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000129
First Posted: October 22, 2009
Last Update Posted: October 22, 2009
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.
Collaborator:
Institute of Cancer Research, United Kingdom
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000129


Contacts
Contact: Dr Robert Huddart 02086613457 robert.huddart@icr.ac.uk
Contact: Bernadette Johnson 02086613434 bernadette.johnson@rmh.nhs.uk

Locations
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
Investigators
Principal Investigator: Dr Robert Huddart Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Dr. Robert Huddart, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01000129     History of Changes
Other Study ID Numbers: CCR3122
First Submitted: October 16, 2009
First Posted: October 22, 2009
Last Update Posted: October 22, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases