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

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ClinicalTrials.gov Identifier: NCT01033682
Recruitment Status : Unknown
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : December 16, 2009
Last Update Posted : December 16, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Rectal Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging
Study Start Date : May 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. The per-patient standard deviation of bladder volume throughout the course of radiotherapy
  2. The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment.
  3. The correlation between bladder volume and small bowel volume planning target volume

Eligibility Criteria

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 Posted: December 16, 2009    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: December 2009