Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Phase 1

Completed

• Conditions: Metastatic Cancer

• Registration Number: NCT00853528
• Lead Sponsor: Boston Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2013-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose - hypofraction	6 weeks	Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Maximum tolerated dose - single fraction	6 weeks	Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Secondary Outcome Measures

Name	Time	Method
Spinal cord response	baseline and then at 6 weeks and 6 months after completion of treatment	Spinal cord response as measured by functional MRI
Assessment of pain	baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment	Pain as measured by the Brief Pain Inventory and Roland scale

Trial Locations

Locations (1)

Boston University Cancer Research Center; 🇺🇸 Boston, Massachusetts, United States