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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033682
First Posted: December 16, 2009
Last Update Posted: December 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Marsden NHS Foundation Trust
  Purpose
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.

Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving radiotherapy to the rectum
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033682


Contacts
Contact: Dr Diana Tait 02086613365 diana.tait@rmh.nhs.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr Diana Tait Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Dr Diana A. Tait, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01033682     History of Changes
Other Study ID Numbers: CCR3175
First Submitted: December 15, 2009
First Posted: December 16, 2009
Last Update Posted: December 16, 2009
Last Verified: December 2009