search
Back to results

Spinal met_radiosurgery/SBRT Study

Primary Purpose

Spine Metastasis

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
SBRT
Radiosurgery
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spine Metastasis focused on measuring spine metastasis, SBRT, Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Clinical Oncology, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: SBRT

Arm B: Radiosurgery

Arm Description

Outcomes

Primary Outcome Measures

Pain control at 3 months post-treatment

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2010
Last Updated
July 23, 2014
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01231061
Brief Title
Spinal met_radiosurgery/SBRT Study
Official Title
Randomized Phase II Study of Image-Guided Radiosurgery / SBRT for Localized Spine Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Metastasis
Keywords
spine metastasis, SBRT, Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: SBRT
Arm Type
Experimental
Arm Title
Arm B: Radiosurgery
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
•24 Gy in 3 fractions to cover at least 90% of the defined target volume
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Intervention Description
16 Gy in 1 fraction to cover at least 90% of the defined target volume
Primary Outcome Measure Information:
Title
Pain control at 3 months post-treatment
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT
Time Frame
4 years
Title
Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT
Time Frame
4 years
Title
Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE
Time Frame
4 years
Title
Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI
Time Frame
4 years
Title
2-year Tumor Control Rate
Time Frame
4 years
Title
Overall Survival
Time Frame
4 years
Title
Quality of life assessment
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael KM KAM, FRCP
Organizational Affiliation
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Spinal met_radiosurgery/SBRT Study

We'll reach out to this number within 24 hrs