Stereotactic Radiosurgery in Treating Patients With Spinal Metastases



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/16/2013
Start Date:January 2009
End Date:February 2014

Use our guide to learn which trials are right for you!

Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine


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.


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.

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

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

PATIENT CHARACTERISTICS:

- 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

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
We found this trial at
1
site
72 East Concord St.
Boston, Massachusetts 02118
617-638-4173
Boston University Cancer Research Center
?
mi
from
Boston, MA
Click here to add this to my saved trials