NCT00168129

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 9, 2011

Status Verified

December 1, 2011

First QC Date

September 9, 2005

Last Update Submit

December 8, 2011

Conditions

Bone Neoplasms

Keywords

tomotherapybone metastasesradiotherapyintensity modulated

Outcome Measures

Primary Outcomes (1)

  • To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy

Secondary Outcomes (4)

  • 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.

Interventions

Helical tomotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • painful metastatic bone disease from any malignancy

You may not qualify if:

  • previous RT to same area
  • contraindications to RT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Rufus Scrimger, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

June 1, 2001

Study Completion

July 1, 2005

Last Updated

December 9, 2011

Record last verified: 2011-12

Locations

CA(1)