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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
Information provided by:
Royal Marsden NHS Foundation Trust Identifier:
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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.

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)

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

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
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Please refer to this study by its identifier: NCT01033682

Contact: Dr Diana Tait 02086613365

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

Responsible Party: Dr Diana A. Tait, Royal Marsden NHS Foundation Trust Identifier: NCT01033682     History of Changes
Other Study ID Numbers: CCR3175
Study First Received: December 15, 2009
Last Updated: December 15, 2009

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 28, 2017