NCT00593320

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
5 years until next milestone

Results Posted

Study results publicly available

March 4, 2015

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2.5 years

First QC Date

January 2, 2008

Results QC Date

February 18, 2015

Last Update Submit

February 18, 2015

Conditions

Spinal Metastases

Keywords

SRS

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Local Control Rate

    6 months after end of treatment

Study Arms (2)

1

ACTIVE COMPARATOR

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

Radiation: Stereotactic Radiosurgery

2

ACTIVE COMPARATOR

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

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic RadiosurgeryRADIATION
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent.
  • Age greater than or equal to 18 years old.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Jeffrey Bradley, M.D.
Organization
Washington University School of Medicine
jbradley@radonc.wustl.edu
314-362-8502

Study Officials

  • Jeffrey Bradley, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 15, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 4, 2015

Results First Posted

March 4, 2015

Record last verified: 2015-02

Locations

US(1)