Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01033682

Acronym

FILL

Enrollment

Registered

2009-12-16

Start date

2009-05-31

Completion date

2010-02-28

Last updated

2009-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

The purpose of this study is to implement and access a newly developed bladder filling protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment unit.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients receiving radical radiotherapy to rectal malignancies. * Age \> 18 years old * No previous lower GI radiotherapy * Written informed consent according to good clinical practice (GCP) and national / local regulations.

Exclusion criteria

* Patients receiving palliative radiotherapy to rectal malignancies. * Patients receiving radical short course preoperative radiotherapy for rectal malignancies. * Patients unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
The percentage of patients who are able to achieve a bladder volume within +/- 30% of planning volume, on all treatment CBCT (cone beam computed tomography) scans	—

Secondary

Measure	Time frame
The per-patient standard deviation of bladder volume throughout the course of radiotherapy	—
The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment.	—
The correlation between bladder volume and small bowel volume planning target volume	—

Countries

United Kingdom

Contacts

Primary ContactDr Diana Tait

diana.tait@rmh.nhs.uk02086613365

Outcome results