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Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

This study has been completed.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00168129
First received: September 9, 2005
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

Resource links provided by NLM:

MedlinePlus related topics: Bone Cancer Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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.

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

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Rufus Scrimger, MD Alberta Health Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00168129     History of Changes
Other Study ID Numbers: NA-15-0007
Study First Received: September 9, 2005
Last Updated: December 8, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Alberta Health Services:
tomotherapy
bone metastases
radiotherapy
intensity modulated

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms
Neoplasm Metastasis
Bone Marrow Diseases
Neoplasms by Site
 Bone Diseases
Musculoskeletal Diseases
Neoplastic Processes
Pathologic Processes
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013