Stereotactic Radiosurgery in Treating Patients With Spinal Metastases - Full Text View

Purpose

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.

Condition	Intervention	Phase
Metastatic Cancer	Other: questionnaire administration Procedure: diffusion tensor imaging Procedure: functional magnetic resonance imaging Radiation: hypofractionated radiation therapy Radiation: stereotactic radiosurgery	Phase 1

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

Resource links provided by NLM:

MedlinePlus related topics: Cancer MRI Scans

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:

Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pain as measured by the Brief Pain Inventory and Roland scale [ Time Frame: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment ] [ Designated as safety issue: No ]
Spinal cord response as measured by functional MRI [ Time Frame: baseline and then at 6 weeks and 6 months after completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Intervention Details:

prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment

prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy

prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter

two to three consecutive daily sessions within one week

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853528

Locations

United States, Massachusetts
Boston University Cancer Research Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-638-8265

Sponsors and Collaborators

Boston Medical Center

Department of Defense

Investigators

Principal Investigator:

Lawrence S. Chin, MD

Boston Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00853528 History of Changes
Other Study ID Numbers:	CDR0000635267, BUMC-H-26577
Study First Received:	February 27, 2009
Last Updated:	November 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Medical Center:

spinal cord metastases

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013