Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00853528
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Minh Tam Truong, Boston Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Other: questionnaire administration Procedure: diffusion tensor imaging Procedure: functional magnetic resonance imaging Radiation: hypo-fractionated SRS Radiation: single-fraction SRS Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase I study with 2 parallel groups of dose escalation using a 3 +3 design to determine the maximum tolerated dose of the radiation with the FDA approved device. There are three dose cohorts in each group, thus 6 arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
Actual Study Start Date : January 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Single-fraction radiosurgery; 16 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 16 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
 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: single-fraction SRS
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
Experimental: Hypo-fractionated radiosurgery; 21 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 21 Gray
 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: hypo-fractionated SRS
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
Experimental: Single-fraction radiosurgery; 18 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 18 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
 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: single-fraction SRS
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
Experimental: Single-fraction radiosurgery; 20 Gray
Subjects able to achieve the spinal cord dose constraints for single-fraction SRS stereotactic radiosurgery Radiation: stereotactic radiotherapy at 20 Gray Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging
 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: single-fraction SRS
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
Experimental: Hypo-fractionated radiosurgery; 24 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 24 Gray
 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: hypo-fractionated SRS
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
Experimental: Hypo-fractionated radiosurgery; 27 Gray
Subjects unable to achieve the spinal cord dose constraints for single-fraction radiosurgery (SRS), based on tumor location and expected tolerance dose to the adjacent normal tissue, will be offered hypo-fractionated SRS (3 fractions) Radiation: stereotactic radiotherapy Questionnaire administration diffusion tensor imaging functional magnetic resonance imaging hypo-fractionated radiation therapy at 27 Gray
 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: hypo-fractionated SRS
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853528


Locations
Layout table for location information
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Minh-Tam Truong, MD Boston Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Minh Tam Truong, BMC Attending Physician, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00853528    
Other Study ID Numbers: H-26577
W81XWH-07-1-0342 ( Other Grant/Funding Number: Dept of Defense )
CDR0000635267 ( Other Identifier: BUMC )
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Minh Tam Truong, Boston Medical Center:
spinal cord metastases
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes