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Completed

NCT Number: NCT00853528

Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire Administration

Other

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

diffusion tensor imaging

Procedure

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

functional magnetic resonance imaging

Procedure

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

hypo-fractionated SRS

Radiation

two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy

single-fraction SRS

Radiation

two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy

Primary outcomes

  1. Maximum tolerated dose - single fraction

    Time frame: 6 weeks

    Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

  2. Maximum tolerated dose - hypofraction

    Time frame: 6 weeks

    Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Secondary outcomes

  1. Assessment of pain

    Time frame: 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

  2. Spinal cord response

    Time frame: baseline and then at 6 weeks and 6 months after completion of treatment

    Spinal cord response as measured by functional MRI

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine

Important dates

Study start
2009
Primary completion
2013
Study completion
2017
First posted
Mar 2, 2009
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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