- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168129
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
December 8, 2011 updated by: Alberta Health services
To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.
Study Overview
Study Type
Interventional
Enrollment
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada
- Cross Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- painful metastatic bone disease from any malignancy
Exclusion Criteria:
- previous RT to same area
- contraindications to RT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy
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Secondary Outcome Measures
Outcome Measure |
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To assess and quantify the acute toxicity of patients with bone metastases treated with helical tomotherapy.
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To measure invivo dosimetry and compare delivered doses to computer-reconstructed dose distribution.
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To determine the maximum tolerated does of palliative radiation give with helical tomotherapy in a single fraction.
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To assess the efficacy (pain control) of radiotherapy given with helical tomotherapy.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
December 9, 2011
Last Update Submitted That Met QC Criteria
December 8, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA-15-0007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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