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CompletedNCT01231061Updated Jul 24, 2014

Spinal met_radiosurgery/SBRT Study

A Phase 2 interventional study of SBRT and Radiosurgery in Spine Metastasis, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-24.

Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Spine Metastasis

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Keywords

  • spine metastasis
  • SBRT
  • Radiosurgery
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 1 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Zubrod Performance Status 0-2;
  3. Age ≥ 18;
  4. History/physical examination within 2 weeks prior to registration;
  5. No pregnancy for women of childbearing potential;
  6. 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.
  7. 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.
  8. 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).
  9. Patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself.
  10. Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
  11. Patients must provide study specific informed consent prior to study entry.

Exclusion criteria

Exclusion Criteria:

  1. Histologies of myeloma or lymphoma.
  2. Patients with any spine metastasis with a rating of \< 4 on the Numerical Rating Pain Scale.
  3. Non-ambulatory patients.
  4. Spine instability due to a compression fracture.
  5. > 50% loss of vertebral body height.
  6. Significant spinal cord compression or displacement.
  7. Patients with rapid neurologic decline.
  8. Bony retropulsion causing neurologic abnormality.
  9. Prior radiation to the index spine.
  10. Patients for whom an MRI of the spine is medically contraindicated.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Arm A: SBRT

    Radiation: SBRT

  • Experimental
    Arm B: Radiosurgery

    Radiation: Radiosurgery

Interventions

  • RadiationSBRT

    •24 Gy in 3 fractions to cover at least 90% of the defined target volume

  • RadiationRadiosurgery

    16 Gy in 1 fraction to cover at least 90% of the defined target volume

06

What researchers measure

Primary outcomes

  1. Pain control at 3 months post-treatment

    Time frame: 4 years

Secondary outcomes

  1. Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT

    Time frame: 4 years

  2. Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT

    Time frame: 4 years

  3. Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE

    Time frame: 4 years

  4. Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI

    Time frame: 4 years

  5. 2-year Tumor Control Rate

    Time frame: 4 years

  6. Overall Survival

    Time frame: 4 years

  7. Quality of life assessment

    Time frame: 4 years

07

Study locations

1 site
  • Department of Clinical Oncology, Prince of Wales Hospital
    Hong Kong, Hong Kong
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01231061
Lead sponsor
Chinese University of Hong Kong
Responsible party
CCTU (Comprehensive Clinical Trial Unit, Chinese University of Hong Kong) — Principal investigator
First posted
Nov 1, 2010
Start date
Nov 2010
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 24, 2014

Study contacts

Michael KM KAM, FRCP
principal investigator · Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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