Spinal met_radiosurgery/SBRT Study

Spine Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231061
• Other study ID #: SYM008
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2010
• Last updated: July 23, 2014
• Start date: November 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spine Metastasis

Intervention

Radiation:
• SBRT
•24 Gy in 3 fractions to cover at least 90% of the defined target volume
• Radiosurgery
16 Gy in 1 fraction to cover at least 90% of the defined target volume

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain control at 3 months post-treatment		4 years	Yes
Secondary	Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT		4 years	No
Secondary	Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT		4 years	No
Secondary	Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE		4 years	Yes
Secondary	Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI		4 years	No
Secondary	2-year Tumor Control Rate		4 years	No
Secondary	Overall Survival		4 years	No
Secondary	Quality of life assessment		4 years	No