Adaptive Planning in Bladder Cancer (APPLY)

October 21, 2009 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden NHS Foundation Trust
        • Principal Investigator:
          • Dr Robert Huddart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Institute of Cancer Research, United Kingdom

Investigators

  • Principal Investigator: Dr Robert Huddart, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Estimate)

October 22, 2009

Last Update Submitted That Met QC Criteria

October 21, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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