Stereotactic Radiosurgery (SRS) for Spine Metastases (SRS)

Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases

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).

Study Overview

• Status: Terminated
• Conditions: Spinal Metastases
• Intervention / Treatment: Radiation: Stereotactic Radiosurgery

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy	Radiation: Stereotactic Radiosurgery
Active Comparator: 2; High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy	Radiation: Stereotactic Radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after completion of treatment
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.	6 months after completion of treatment
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.	6 months after completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after end of treatment

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Jeffrey Bradley, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Estimate): March 4, 2015
• Last Update Submitted That Met QC Criteria: February 18, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: SRS
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 07-0658