Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00853528
First received: February 27, 2009
Last updated: January 28, 2015
Last verified: January 2015
  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: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

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: June 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiosurgery
Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypofractionated radiation therapy
Other: questionnaire administration
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
Procedure: diffusion tensor imaging
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
Procedure: functional magnetic resonance imaging
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter
Radiation: hypofractionated radiation therapy
two to three consecutive daily sessions within one week
Radiation: stereotactic radiosurgery
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Lawrence S. Chin, MD Boston Medical Center
  More Information

Additional Information:
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: January 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
spinal cord metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2015