A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain

November 18, 2014 updated by: Washington University School of Medicine

A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Age ≥ 18
  • Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group -1
1000 cGY radiation
Radiation: Stereotactic radiotherapy
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.
Other Names:
  • Stereotactic Radiosurgery
  • Paraspinal Metastasis
  • Prior Spinal Irradiation
Experimental: Group 1
1200 cGY radiation
Radiation: Stereotactic radiotherapy
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.
Other Names:
  • Stereotactic Radiosurgery
  • Paraspinal Metastasis
  • Prior Spinal Irradiation
Experimental: Group 2
1400 cGY radiation
Radiation: Stereotactic radiotherapy
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.
Other Names:
  • Stereotactic Radiosurgery
  • Paraspinal Metastasis
  • Prior Spinal Irradiation
Experimental: Group 3
1600 cGY radiation
Radiation: Stereotactic radiotherapy
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.
Other Names:
  • Stereotactic Radiosurgery
  • Paraspinal Metastasis
  • Prior Spinal Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field
Time Frame: 4 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Pain Control for Each Dose Level.
Time Frame: 4 years
A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.
4 years
Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.
Time Frame: 4 weeks
4 weeks
Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.
Time Frame: 4 years
4 years
Quality of Life
Time Frame: 4 years

As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)

Participant can chose on a scale of 0-4 with 0=not at all and 4=very much.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-1149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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