Adaptive Planning in Bladder Cancer

Bladder Cancer Clinical Trial

— APPLY  

Official title:

Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01000129
• Other study ID #: CCR3122
• Status: Recruiting
• Phase: Phase 2
• First received: October 16, 2009
• Last updated: October 21, 2009
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Robert Huddart
• Phone: 02086613457
• Email: robert.huddart[@]icr.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)
Planning CT scan performed by qualified planning radiographers
• Cone beam CT acquisition
Cone beam CT acquisition performed by therapy radiographers who have training and experience of using cone beam CT.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No