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Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

This study has been completed.

Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00168129
  Purpose

To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.


Condition Intervention Phase
Bone Neoplasms
Procedure: Helical tomotherapy
Phase I

MedlinePlus related topics:   Bone Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

Further study details as provided by Alberta Cancer Board:

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 tomotherpay in a single fraction.
  • To assess the efficacy (pain control) of radiotherapy given with helical tomotherapy.

Estimated Enrollment:   10
Study Start Date:   June 2001
Estimated Study Completion Date:   July 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • painful metastatic bone disease from any malignancy

Exclusion Criteria:

  • previous RT to same area
  • contraindications to RT
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168129

Sponsors and Collaborators
Alberta Cancer Board

Investigators
Principal Investigator:     Rufus Scrimger, MD     Alberta Cancer Board    
  More Information


Study ID Numbers:   NA-15-0007
First Received:   September 9, 2005
Last Updated:   November 6, 2006
ClinicalTrials.gov Identifier:   NCT00168129
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Alberta Cancer Board:
tomotherapy  
bone metastases  
radiotherapy  
intensity modulated  

Study placed in the following topic categories:
Musculoskeletal Diseases
Bone Neoplasms
Bone neoplasms
Neoplasm Metastasis
Bone Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on September 22, 2008




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