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Reproducibility of an Immobilization Device (BodyFIX) - Hodgkins/Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00232440
First received: October 3, 2005
Last updated: August 10, 2010
Last verified: August 2010
History of Changes

October 3, 2005
August 10, 2010
January 2003
June 2009   (final data collection date for primary outcome measure)
The primary outcome for the study is the average deviation in set-up.
Same as current
Complete list of historical versions of study NCT00232440 on ClinicalTrials.gov Archive Site
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Reproducibility of an Immobilization Device (BodyFIX) - Hodgkins/Lymphoma
A Study to Examine the Reproducibility of an Immobilization Device (BodyFIX ) to Deliver High Precision Radiation Therapy for Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma

Radiation therapy has a well-established role in the treatment of Hodgkin's Disease and non-Hodgkin's Lymphoma. With technological developments, 3-D Dimensional (3D) planning has evolved as a highly precise treatment planning option. High-precision radiation therapy has the potential for more accurate dose delivery to the tumour volume and can result in a greater sparing of normal tissue. An important component of safe radiotherapy delivery is the feasibility and reproducibility of current and new immobilization devices for highly conformal treatment.

The purpose of this study is to determine the reproducibility of an immobilization device known as BodyFIX(TM) using conventional treatment techniques.
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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hodgkin's Disease
  • Lymphoma, Non-Hodgkin
Device: BodyFIX
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients undergoing curative or palliative treatment in whom it is considered that immobilization of part or all of an anatomical region would be of benefit to their care.

Exclusion Criteria:

  • Any case where ideal treatment may be compromised with use of immobilization method.
  • If the patient has any social issues, language barriers resulting in difficulties comprehending the nature of the study, or poor performance status, that could compromise compliance with the study guidelines.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00232440
UHN REB 02-0526-C
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University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Alex Sun, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP