Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

This study has been completed.
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00168129
First received: September 9, 2005
Last updated: December 8, 2011
Last verified: December 2011
  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:


Further study details as provided by AHS Cancer Control Alberta:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Rufus Scrimger, MD AHS Cancer Control Alberta
  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 AHS Cancer Control Alberta:
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 July 22, 2014