Adaptive Planning in Bladder Cancer (APPLY)
Recruitment status was Recruiting
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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 |
- 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. [ Designated as safety issue: No ]
| 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) |
-
Other: Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Dr Robert Huddart | 02086613457 | robert.huddart@icr.ac.uk |
| Contact: Bernadette Johnson | 02086613434 | bernadette.johnson@rmh.nhs.uk |
| United Kingdom | |
| Royal Marsden NHS Foundation Trust | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Principal Investigator: Dr Robert Huddart | |
| Principal Investigator: | Dr Robert Huddart | Royal Marsden NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Dr. Robert Huddart, Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01000129 History of Changes |
| Other Study ID Numbers: | CCR3122 |
| Study First Received: | October 16, 2009 |
| Last Updated: | October 21, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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 |
ClinicalTrials.gov processed this record on May 19, 2013