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Stereotactic Radiosurgery (SRS) for Spine Metastases (SRS)

Primary Purpose

Spinal Metastases

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring SRS

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent.
  • Age greater than or equal to 18 years old.
  • Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
  • Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
  • Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
  • Maximum tumor size less than or equal to 5 cm.
  • Zubrod performance status of less than or equal to 3.
  • Life expectancy of greater than or equal to 3 months.
  • Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria:

  • No prior radiation delivered to the involved area
  • No evidence of spinal instability requiring urgent surgical intervention.
  • No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
  • No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
  • No pregnant or lactating women.
  • No active systemic infection.
  • No evidence of myelopathy or cauda equina syndrome on clinical evaluation

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy

High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy

Outcomes

Primary Outcome Measures

Pain Control Rate as Measured by the The Brief Pain Inventory
The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.
Musculoskeletal Function as Measured by the Oswestry Disability Index
The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.
Quality of Life as Measured by the FACT-CNS Questionnaire
The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.

Secondary Outcome Measures

Local Control Rate
Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.

Full Information

First Posted
January 2, 2008
Last Updated
February 18, 2015
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00593320
Brief Title
Stereotactic Radiosurgery (SRS) for Spine Metastases
Acronym
SRS
Official Title
Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to low accrual
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).
Detailed Description
This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
SRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
Arm Title
2
Arm Type
Active Comparator
Arm Description
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiosurgery
Primary Outcome Measure Information:
Title
Pain Control Rate as Measured by the The Brief Pain Inventory
Description
The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.
Time Frame
6 months after completion of treatment
Title
Musculoskeletal Function as Measured by the Oswestry Disability Index
Description
The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.
Time Frame
6 months after completion of treatment
Title
Quality of Life as Measured by the FACT-CNS Questionnaire
Description
The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.
Time Frame
6 months after completion of treatment
Secondary Outcome Measure Information:
Title
Local Control Rate
Description
Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.
Time Frame
6 months after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent. Age greater than or equal to 18 years old. Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma). Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS. Metastatic disease must be symptomatic (causing either pain or neurologic symptoms). Maximum tumor size less than or equal to 5 cm. Zubrod performance status of less than or equal to 3. Life expectancy of greater than or equal to 3 months. Women/Men of childbearing potential must use effective contraception. Exclusion Criteria: No prior radiation delivered to the involved area No evidence of spinal instability requiring urgent surgical intervention. No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention. No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery. No pregnant or lactating women. No active systemic infection. No evidence of myelopathy or cauda equina syndrome on clinical evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bradley, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Stereotactic Radiosurgery (SRS) for Spine Metastases

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