NCT00802659

Brief Summary

This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.

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 Mar 2008

Shorter than P25 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

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
6 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

December 5, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

December 4, 2008

Results QC Date

November 10, 2014

Last Update Submit

November 18, 2014

Conditions

Metastases

Outcome Measures

Primary Outcomes (1)

  • Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field

    Optimal dose 1. the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications 2. the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first

    4 weeks

Secondary Outcomes (4)

  • Duration of Pain Control for Each Dose Level.

    4 years

  • Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.

    4 weeks

  • Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.

    4 years

  • Quality of Life

    4 years

Study Arms (4)

Group -1

EXPERIMENTAL

1000 cGY radiation

Radiation: Stereotactic radiotherapy

Group 1

EXPERIMENTAL

1200 cGY radiation

Radiation: Stereotactic radiotherapy

Group 2

EXPERIMENTAL

1400 cGY radiation

Radiation: Stereotactic radiotherapy

Group 3

EXPERIMENTAL

1600 cGY radiation

Radiation: Stereotactic radiotherapy

Interventions

Stereotactic radiotherapyRADIATION

This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment patient's pain, and how many side effects participants before you have experienced.

Also known as: Stereotactic Radiosurgery, Paraspinal Metastasis, Prior Spinal Irradiation
Group -1Group 1Group 2Group 3

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
  • Have had prior radiation to area of spine felt to be cause of patient's pain
  • Zubrod performance status of 0-3
  • Life expectancy of ≥ 3 months
  • Signed informed consent prior to registration to study
  • Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.

You may not qualify if:

  • Women who are pregnant or nursing
  • Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
  • No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
  • No initiation of chemotherapy within 15 days of trial entry.
  • No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
  • 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

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

The study was closed early due to slow accrual.

Results Point of Contact

Title
Jeffrey Bradley, M.D.
Organization
Washington University School of Medicine
jbradley@radonc.wustl.edu
314-362-8525

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

December 5, 2014

Results First Posted

November 18, 2014

Record last verified: 2014-11

Locations

US(1)