Adaptive Planning in Bladder Cancer

NCT ID: NCT01000129

Last Updated: 2009-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Interventions

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Adaptive-Planning Organ Localisation (A-POLO) (Planning CT scan)

Planning CT scan performed by qualified planning radiographers

Intervention Type OTHER

Cone beam CT acquisition

Cone beam CT acquisition performed by therapy radiographers who have training and experience of using cone beam CT.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Marsden NHS Foundation Trust

Principal Investigators

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Dr Robert Huddart

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr Robert Huddart

Role: CONTACT

02086613457

Bernadette Johnson

Role: CONTACT

02086613434

Other Identifiers

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CCR3122

Identifier Type: -

Identifier Source: org_study_id

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