Spine MetastasisPhase 2NCT01231061

Spinal met_radiosurgery/SBRT Study

A Phase 2 study testing SBRT and Radiosurgery in people with Spine Metastasis, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/SBRT Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spine Metastasis
What is being tested?: SBRT and Radiosurgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteHong Kong
Study dates: Nov 2010to Jul 2014
Phase: Phase 2
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

The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study (bone scan, PET, CT, or MRI). A solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. A paraspinal mass ≤ 5 cm is allowed.
Zubrod Performance Status 0-2;
Age ≥ 18;
History/physical examination within 2 weeks prior to registration;
No pregnancy for women of childbearing potential;
MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement. MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. If possible, an MRI with thin slice thickness (<1mm) with 3D reconstruction quality would be most preferable for treatment planning purpose.

Show all 11Show fewer

Numerical Rating Pain Scale within 1 week prior to registration. The patient must have a score on the Scale of ≥ 4 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; see Appendix IV for the standardized neurological examination. Patients with mild to moderate neurological signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
Patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself.
Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
Patients must provide study specific informed consent prior to study entry.

Who cannot join

Histologies of myeloma or lymphoma.
Patients with any spine metastasis with a rating of < 4 on the Numerical Rating Pain Scale.
Non-ambulatory patients.
Spine instability due to a compression fracture.
> 50% loss of vertebral body height.
Significant spinal cord compression or displacement.

Show all 10Show fewer

Patients with rapid neurologic decline.
Bony retropulsion causing neurologic abnormality.
Prior radiation to the index spine.
Patients for whom an MRI of the spine is medically contraindicated.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong

Other trials in Hong Kong

About this study

Official title: Randomized Phase II Study of Image-Guided Radiosurgery / SBRT for Localized Spine Metastasis

Demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/SBRT

Conditions: Spine Metastasis
Being tested: SBRT, Radiosurgery
Keywords: spine metastasis, SBRT, Radiosurgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBRTRadiation
•24 Gy in 3 fractions to cover at least 90% of the defined target volume
RadiosurgeryRadiation
16 Gy in 1 fraction to cover at least 90% of the defined target volume

Study groups in NCT01231061
Study group	Role	What they receive
Arm A: SBRT	Experimental	Not described Receives: Radiation: SBRT
Arm B: Radiosurgery	Experimental	Not described Receives: Radiation: Radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain control at 3 months post-treatment
Measured: 4 years

Secondary outcomes (7)

Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT
Measured: 4 years
Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT
Measured: 4 years
Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE
Measured: 4 years
Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI
Measured: 4 years
2-year Tumor Control Rate
Measured: 4 years
Overall Survival
Measured: 4 years
Quality of life assessment
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Jul 2014

First posted1 Nov 2010 (estimated)
Study startNov 2010
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spine MetastasisStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01231061
Sponsor's protocol ID: SYM008
Status last verified: Jul 2014
First submitted: 29 Oct 2010
Last updated: 24 Jul 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Not yet recruiting
Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
Spine Metastasis, Stereotactic Body Radiation Therapy (SBRT)
Not yet recruitingPhase 4
Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT)
Recruiting
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
Neoplasm Metastasis, Spinal Cord Diseases
RecruitingObservational study
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation
Bone Cancer Metastatic, Radiofrequency Ablation

All Spine Metastasis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase II Study of Image-Guided Radiosurgery / SBRT for Localized Spine Metastasis
ClinicalTrials.gov ID: NCT01231061
Acronym / sponsor ID: SYM008
Conditions: Spine Metastasis
Keywords: spine metastasis, SBRT, Radiosurgery
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: Nov 2010
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 1 Nov 2010 (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.

Demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/SBRT

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: SBRT	Experimental	Radiation: SBRT
Arm B: Radiosurgery	Experimental	Radiation: Radiosurgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study (bone scan, PET, CT, or MRI). A solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. A paraspinal mass ≤ 5 cm is allowed.
Zubrod Performance Status 0-2;
Age ≥ 18;
History/physical examination within 2 weeks prior to registration;
No pregnancy for women of childbearing potential;

Key exclusion criteria (10 listed)

Histologies of myeloma or lymphoma.
Patients with any spine metastasis with a rating of < 4 on the Numerical Rating Pain Scale.
Non-ambulatory patients.
Spine instability due to a compression fracture.
> 50% loss of vertebral body height.

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
SBRT•24 Gy in 3 fractions to cover at least 90% of the defined target volume	Radiation	Arm A: SBRT
Radiosurgery16 Gy in 1 fraction to cover at least 90% of the defined target volume	Radiation	Arm B: Radiosurgery

Primary outcome

Pain control at 3 months post-treatment
Time frame: 4 years

7 secondary outcomes

Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT
Time frame: 4 years
Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT
Time frame: 4 years
Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE
Time frame: 4 years
Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI
Time frame: 4 years
2-year Tumor Control Rate
Time frame: 4 years
Overall Survival
Time frame: 4 years
Quality of life assessment
Time frame: 4 years

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 24 Jul 2014.

Related trials for Spine Metastasis

Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Not yet recruiting
Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
Spine Metastasis, Stereotactic Body Radiation Therapy (SBRT)
Not yet recruitingPhase 4
Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT)
Recruiting
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
Neoplasm Metastasis, Spinal Cord Diseases
RecruitingObservational study
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By Positron Emission Computed Tomography (PET-CT) Confirmation
Bone Cancer Metastatic, Radiofrequency Ablation

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.

Michael KM KAM, FRCP principal investigator

Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT and Radiosurgery in people with Spine Metastasis, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 11 inclusion and 10 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 24 Jul 2014. 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 Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Pain control at 3 months post-treatment (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01231061.

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 24 Jul 2014; AzTrials last refreshed its copy on 28 Oct 2026.