Spinal met_radiosurgery/SBRT Study

NCT ID: NCT01231061

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-07-31

Brief Summary

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

Conditions

Spine Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: SBRT

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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

Arm B: Radiosurgery

Group Type: EXPERIMENTAL

Radiosurgery

Intervention Type: RADIATION

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

Interventions

SBRT

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

Intervention Type: RADIATION

Radiosurgery

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CCTU

Comprehensive Clinical Trial Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael KM KAM, FRCP

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

SYM008

Identifier Type: -

Identifier Source: org_study_id