Clinical trial NCT01231061: Spinal met_radiosurgery/SBRT Study
Official title: Randomized Phase II Study of Image-Guided Radiosurgery / SBRT for Localized Spine Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spine Metastasis
Keywords: spine metastasis
SBRT
Radiosurgery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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:

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.

Primary outcomes:
measure: Pain control at 3 months post-treatment
timeFrame: 4 years
Secondary outcomes:
measure: Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT
timeFrame: 4 years
measure: Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT
timeFrame: 4 years
measure: Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE
timeFrame: 4 years
measure: Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI
timeFrame: 4 years
measure: 2-year Tumor Control Rate
timeFrame: 4 years
measure: Overall Survival
timeFrame: 4 years
measure: Quality of life assessment
timeFrame: 4 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Michael KM KAM, FRCP
role: PRINCIPAL_INVESTIGATOR
References: