Bone NeoplasmsPhase 1NCT00168129
Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
A Phase 1 study testing Helical tomotherapy in people with Bone Neoplasms, run by Alberta Health services at 1 site in Canada.
Trial summary
To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Neoplasms
- What is being tested?
- Helical tomotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2001to Jul 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- painful metastatic bone disease from any malignancy
Who cannot join
- previous RT to same area
- contraindications to RT
Trial locations and contacts
1 site in 1 country.
About this study
To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.
- Conditions
- Bone Neoplasms
- Being tested
- Helical tomotherapy
- Keywords
- tomotherapy, bone metastases, radiotherapy, intensity modulated
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helical tomotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2001
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Rufus Scrimger, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168129
- Sponsor's protocol ID
- NA-15-0007
- Status last verified
- Dec 2011
- First submitted
- 9 Sep 2005
- Last updated
- 9 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helical Tomotherapy as a Radiotherapy Technique for Treating Bone Metastases
- ClinicalTrials.gov ID
- NCT00168129
- Acronym / sponsor ID
- NA-15-0007
- Conditions
- Bone Neoplasms
- Keywords
- tomotherapy, bone metastases, radiotherapy, intensity modulated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- Jul 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of a single fraction of radiotherapy using helical tomotherapy to treat bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- painful metastatic bone disease from any malignancy
Key exclusion criteria (2 listed)
- previous RT to same area
- contraindications to RT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helical tomotherapy | Procedure or surgery | – |
Primary outcome
To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rufus Scrimger, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Helical tomotherapy in people with Bone Neoplasms, run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To deliver a single fraction of radiotherapy safely to patients with bone metastases using helical tomotherapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2011; AzTrials last refreshed its copy on 6 Nov 2026.