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Adaptive Planning in Bladder Cancer

Information source: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bladder Cancer

Intervention: Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan) (Other); Cone beam CT acquisition (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Royal Marsden NHS Foundation Trust

Official(s) and/or principal investigator(s):
Dr Robert Huddart, Principal Investigator, Affiliation: Royal Marsden NHS Foundation Trust

Overall contact:
Dr Robert Huddart, Phone: 02086613457, Email: robert.huddart@icr.ac.uk

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.

Clinical Details

Official title: Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy

Study design: Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Primary outcome: 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.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dr Robert Huddart, Phone: 02086613457, Email: robert.huddart@icr.ac.uk

Royal Marsden NHS Foundation Trust, Sutton, Surrey SM2 5PT, United Kingdom; Recruiting
Dr Robert Huddart, Principal Investigator
Additional Information

Starting date: January 2009
Last updated: October 21, 2009

Page last updated: August 23, 2015

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