Back to resultsHelical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
Primary Purpose
Bone Neoplasms
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Helical tomotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bone Neoplasms focused on measuring tomotherapy, bone metastases, radiotherapy, intensity modulated
Eligibility Criteria
Inclusion Criteria: painful metastatic bone disease from any malignancy Exclusion Criteria: previous RT to same area contraindications to RT
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy
Secondary Outcome Measures
To assess and quantify the acute toxicity of patients with bone metastases treated with helical tomotherapy.
To measure invivo dosimetry and compare delivered doses to computer-reconstructed dose distribution.
To determine the maximum tolerated does of palliative radiation give with helical tomotherapy in a single fraction.
To assess the efficacy (pain control) of radiotherapy given with helical tomotherapy.
Full Information
NCT ID
NCT00168129
First Posted
September 9, 2005
Last Updated
December 8, 2011
Sponsor
Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT00168129
Brief Title
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
Official Title
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
4. Oversight
5. Study Description
Brief Summary
To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Neoplasms
Keywords
tomotherapy, bone metastases, radiotherapy, intensity modulated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Helical tomotherapy
Primary Outcome Measure Information:
Title
To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy
Secondary Outcome Measure Information:
Title
To assess and quantify the acute toxicity of patients with bone metastases treated with helical tomotherapy.
Title
To measure invivo dosimetry and compare delivered doses to computer-reconstructed dose distribution.
Title
To determine the maximum tolerated does of palliative radiation give with helical tomotherapy in a single fraction.
Title
To assess the efficacy (pain control) of radiotherapy given with helical tomotherapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
painful metastatic bone disease from any malignancy
Exclusion Criteria:
previous RT to same area
contraindications to RT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rufus Scrimger, MD
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
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