Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

Bone Neoplasms Clinical Trial

Official title:

Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168129
• Other study ID #: NA-15-0007
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: December 8, 2011
• Start date: June 2001
• Est. completion date: July 2005

Study information

• Verified date: December 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• painful metastatic bone disease from any malignancy

Exclusion Criteria:

• previous RT to same area

• contraindications to RT

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms

Intervention

Procedure:
• Helical tomotherapy

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy
Secondary	To assess and quantify the acute toxicity of patients with bone metastases treated with helical tomotherapy.
Secondary	To measure invivo dosimetry and compare delivered doses to computer-reconstructed dose distribution.
Secondary	To determine the maximum tolerated does of palliative radiation give with helical tomotherapy in a single fraction.
Secondary	To assess the efficacy (pain control) of radiotherapy given with helical tomotherapy.