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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 because the information has not been verified recently.
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01033682
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The per-patient standard deviation of bladder volume throughout the course of radiotherapy [ Designated as safety issue: No ]
  • The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment. [ Designated as safety issue: No ]
  • The correlation between bladder volume and small bowel volume planning target volume [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Diana A. Tait, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01033682     History of Changes
Other Study ID Numbers: CCR3175
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on November 20, 2014