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A Phase II Study of Spinal Radiosurgery (RAD0408)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573872
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : October 20, 2017
Last Update Posted : December 5, 2017
Health Services Foundation
The Kirklin Clinic at Acton Road
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

Brief Summary:
Phase I of the study (motion and quality assurance [QA] study) is being used to determine intrafraction target motion and define quality assurance procedures for single fraction spinal radiosurgery. The Phase II portion of the study is being used to estimate the palliative response (pain or relief of neurologic symptoms) and local control for single fraction radiosurgery delivered with TomoTherapy and to assess the acute and late toxicity of spinal radiosurgery.

Condition or disease Intervention/treatment Phase
Neoplasm Arteriovenous Malformations Radiation: Radiosurgery Not Applicable

Detailed Description:

Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study.

Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:

Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = <50% CTV dose/No previous RT = <80% CTV dose.

Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.

# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.

*Previous RT:

  • greater than six months since completion of RT
  • at least 20 Gy, but no more than 50 Gy

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Spinal Radiosurgery
Actual Study Start Date : April 2005
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Spinal Radiosurgery
Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.
Radiation: Radiosurgery

Phase I: 20-25 Gy in 5 fractions

Phase II: 9-24 GY in 1 fraction

Primary Outcome Measures :
  1. Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy [ Time Frame: 2 years ]
    Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as "worse", "stable", "better", or "completely resolved". In the reporting "better" or "completely resolved" indicates response to treatment.

  2. Assess the Acute and Late Toxicity of Spinal Radiosurgery [ Time Frame: 2 years ]
    CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.

  3. Number of Participants With Lack of Tumor Growth at Last Follow-up [ Time Frame: 2 years ]
    Lack of tumor growth by CT or MRI at last follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All subjects must have history of histologically confirmed neoplasm or radiographically-diagnosed AVM. Patients without a prior tissue diagnosis but who have a radiographically characteristic lesion are eligible if there is consensus agreement of the diagnosis in the UAB Neuro-oncology Tumor Board.
  2. ECOG performance status of less than or equal to 2
  3. Age greater than 18
  4. Life expectancy greater than 12 weeks
  5. Subjects given written informed consent

Exclusion Criteria:

  1. Cytotoxic chemotherapy within 7 days of treatment
  2. Insufficient recovery from all active toxicities of prior therapies
  3. Epidural spinal cord compression requiring immediate neurosurgical decompression. If a patient requires immediate surgery for neurologic compromise, they may still be eligible post operatively if tumor was incompletely resected.
  4. Patient is non-ambulatory. Optimization of pretreatment neurologic function with steroids is allowed. Ambulation with assistance of walker or cane is allowed.
  5. Patient is pregnant and it is judged by the treating Radiation Oncologist that spinal radiosurgery would place the fetus in unacceptable danger.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573872

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United States, Alabama
University of Alabama at Birmingham/The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Health Services Foundation
The Kirklin Clinic at Acton Road
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Principal Investigator: John B. Fiveash, M.D. University of Alabama at Birmingham
Nieder C: Recommendation of Human Spinal Cord Re-irradiation Dose Based on Data From 39 Patients. Int J Radiat Oncol Biol Phys 57:373, 2003

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Responsible Party: John Fiveash, MD, Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology, University of Alabama at Birmingham Identifier: NCT00573872    
Other Study ID Numbers: F050103003
First Posted: December 14, 2007    Key Record Dates
Results First Posted: October 20, 2017
Last Update Posted: December 5, 2017
Last Verified: October 2017
Keywords provided by John Fiveash, MD, University of Alabama at Birmingham:
Phase II
Additional relevant MeSH terms:
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Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases