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Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

Phase 1
18 Years
Open (Enrolling)
Metastatic Cancer

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Trial Information

Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine


- To implement CyberKnife® technology for improving palliation in patients with spinal

- 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.

Inclusion Criteria


- 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

- No tumors that are exquisitely radiosensitive and controlled with conventional
radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)


- Karnofsky performance status 60-100%

- Life expectancy ≥ 6 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be ambulatory

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Lawrence S. Chin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

February 2014

Related Keywords:

  • Metastatic Cancer
  • spinal cord metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Boston University Cancer Research Center Boston, Massachusetts  02118