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Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
diffusion tensor imaging
functional magnetic resonance imaging
hypo-fractionated SRS
single-fraction SRS
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring spinal cord metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boston University Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Single-fraction radiosurgery; 16 Gray

Hypo-fractionated radiosurgery; 21 Gray

Single-fraction radiosurgery; 18 Gray

Single-fraction radiosurgery; 20 Gray

Hypo-fractionated radiosurgery; 24 Gray

Hypo-fractionated radiosurgery; 27 Gray

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Maximum tolerated dose - single fraction
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Maximum tolerated dose - hypofraction
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Secondary Outcome Measures

Assessment of pain
Pain as measured by the Brief Pain Inventory and Roland scale
Spinal cord response
Spinal cord response as measured by functional MRI

Full Information

First Posted
February 27, 2009
Last Updated
July 17, 2017
Sponsor
Boston Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00853528
Brief Title
Stereotactic Radiosurgery in Treating Patients With Spinal Metastases
Official Title
Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
spinal cord metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-fraction radiosurgery; 16 Gray
Arm Type
Experimental
Arm Description
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
Arm Title
Hypo-fractionated radiosurgery; 21 Gray
Arm Type
Experimental
Arm Description
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
Arm Title
Single-fraction radiosurgery; 18 Gray
Arm Type
Experimental
Arm Description
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
Arm Title
Single-fraction radiosurgery; 20 Gray
Arm Type
Experimental
Arm Description
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
Arm Title
Hypo-fractionated radiosurgery; 24 Gray
Arm Type
Experimental
Arm Description
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
Arm Title
Hypo-fractionated radiosurgery; 27 Gray
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
Intervention Type
Procedure
Intervention Name(s)
diffusion tensor imaging
Intervention Description
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
Intervention Type
Procedure
Intervention Name(s)
functional magnetic resonance imaging
Intervention Description
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter
Intervention Type
Radiation
Intervention Name(s)
hypo-fractionated SRS
Intervention Description
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
Intervention Type
Radiation
Intervention Name(s)
single-fraction SRS
Intervention Description
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 Outcome Measure Information:
Title
Maximum tolerated dose - single fraction
Description
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Time Frame
6 weeks
Title
Maximum tolerated dose - hypofraction
Description
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assessment of pain
Description
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
Title
Spinal cord response
Description
Spinal cord response as measured by functional MRI
Time Frame
baseline and then at 6 weeks and 6 months after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minh-Tam Truong, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.

Learn more about this trial

Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

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