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Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

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.

Safety Issue:

No

Principal Investigator

Dr Robert Huddart

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CCR3122

NCT ID:

NCT01000129

Start Date:

January 2009

Completion Date:

December 2010

Related Keywords:

  • Bladder Cancer
  • Radiotherapy
  • Bladder cancer
  • Adaptive planning
  • Urinary Bladder Neoplasms

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