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

This study has been terminated.
(Terminated due to low accrual)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00802659
First received: December 4, 2008
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Metastases
Radiation: Stereotactic radiotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • Duration of Pain Control for Each Dose Level. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.

  • Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    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.



Enrollment: 2
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802659

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey Bradley, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00802659     History of Changes
Other Study ID Numbers: 07-1149
Study First Received: December 4, 2008
Results First Received: November 10, 2014
Last Updated: November 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014