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A Phase II Study of Spinal Radiosurgery (RAD0408)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573872
First Posted: December 14, 2007
Last Update Posted: October 20, 2017
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.
Collaborators:
Health Services Foundation
The Kirklin Clinic at Acton Road
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham
  Purpose
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 Intervention
Neoplasm Arteriovenous Malformations Radiation: Radiosurgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Spinal Radiosurgery

Further study details as provided by John Fiveash, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Estimate the 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.

  • 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.

  • Access Local Tumor Control [ Time Frame: 2 years ]
    Lack of tumor growth by CT or MRI at last follow-up


Enrollment: 43
Actual Study Start Date: April 2005
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00573872


Locations
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
Investigators
Principal Investigator: John B. Fiveash, M.D. University of Alabama at Birmingham
  More Information

Publications:
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

Responsible Party: John Fiveash, MD, Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00573872     History of Changes
Other Study ID Numbers: F050103003
T0408240012
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: August 8, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017

Keywords provided by John Fiveash, MD, University of Alabama at Birmingham:
Radiosurgery
Phase II
Cancer
Spinal
AVM

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms