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

Phase 2
18 Years
Open (Enrolling)
Spine Metastasis

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Trial Information

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

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

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:

1. Histologies of myeloma or lymphoma.

2. Patients with any spine metastasis with a rating of < 4 on the Numerical Rating Pain

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain control at 3 months post-treatment

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Michael KM KAM, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

November 2010

Completion Date:

July 2014

Related Keywords:

  • Spine Metastasis
  • spine metastasis
  • SBRT
  • Radiosurgery
  • Neoplasm Metastasis