Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Boston Medical Center (BMC)

Status and phase

Completed

Phase 1

Conditions

Metastatic Cancer

Treatments

Procedure: functional magnetic resonance imaging

Other: questionnaire administration

Radiation: hypo-fractionated SRS

Procedure: diffusion tensor imaging

Radiation: single-fraction SRS

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00853528

W81XWH-07-1-0342 (Other Grant/Funding Number)

CDR0000635267 (Other Identifier)

H-26577

Details and patient eligibility

About

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.

Full description

OBJECTIVES:

To implement CyberKnife® technology for improving palliation in patients with spinal metastases.
To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients.
To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery.

OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.

Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 2 years.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic spinal tumor
- Localized spinal metastasis, defined as one of the following:
  - Solitary spinal metastasis
  - Two contiguous spinal levels
    - No more than 2 adjacent spinal levels involved by a single tumor
  - Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12)
- Tumor size ≤ 5 cm

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
Life expectancy ≥ 6 months
Negative pregnancy test
Fertile patients must use effective contraception
Must be ambulatory

Exclusion criteria

Not pregnant or nursing
No spinal instability
No rapid neurological decline
No bony retropulsions causing neurological abnormalities
No total paraplegia for > 48 hours
No psychological issues that would preclude completion of study treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields
No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance
No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 6 patient groups

Single-fraction radiosurgery; 16 Gray

Experimental group

Description:

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Treatment:

Other: questionnaire administration

Procedure: functional magnetic resonance imaging

Radiation: single-fraction SRS

Procedure: diffusion tensor imaging

Hypo-fractionated radiosurgery; 21 Gray

Experimental group

Description:

Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray

Treatment:

Other: questionnaire administration

Procedure: functional magnetic resonance imaging

Procedure: diffusion tensor imaging

Radiation: hypo-fractionated SRS

Single-fraction radiosurgery; 18 Gray

Experimental group

Description:

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Treatment:

Other: questionnaire administration

Procedure: functional magnetic resonance imaging

Radiation: single-fraction SRS

Procedure: diffusion tensor imaging

Single-fraction radiosurgery; 20 Gray

Experimental group

Description:

Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging

Treatment:

Other: questionnaire administration

Procedure: functional magnetic resonance imaging

Radiation: single-fraction SRS

Procedure: diffusion tensor imaging

Hypo-fractionated radiosurgery; 24 Gray

Experimental group

Description:

Treatment:

Other: questionnaire administration

Procedure: functional magnetic resonance imaging

Procedure: diffusion tensor imaging