Last updated on May 2017

Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis


Brief description of study

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis. (phase II completed as of 8-30-11)

Detailed Study Description

OBJECTIVES: Primary - Determine the feasibility of successfully delivering image-guided radiosurgery or stereotactic body radiotherapy (SBRT) in patients with spine metastases in a cooperative group setting. (Phase II) (completed as of 8-30-11) - Determine whether image-guided radiosurgery or SBRT (single dose of 16 Gy) improves pain control (as measured by the 11-point Numerical Rating Pain Scale [NRPS]) compared to conventional external beam radiotherapy (single dose of 8 Gy). (Phase III) Secondary - Determine whether image-guided radiosurgery or SBRT improves the rapidity of pain response and increases the duration of pain response at the treated site(s) compared to conventional external beam radiotherapy, as measured by the NRPS. (Phase III) - Compare adverse events associated with these treatment regimens, as measured by NCI CTCAE v3.0 criteria. (Phase III) - Evaluate the long-term effects (24 months) of image-guided radiosurgery or SBRT on the vertebral bone (e.g., compression fracture) and the spinal cord, as measured by MRI. (Phase III) OUTLINE: This is a multicenter, phase II study (completed as of 8-30-11) followed by a randomized phase III study. Patients enrolled in the phase III portion are stratified according to the number of spine metastases to be treated (1 vs 2-3) and the type of tumor (radioresistant [including soft tissue sarcomas, melanomas, and renal cell carcinomas] vs other). - Phase II: Patients undergo 1 high-dose image-guided radiosurgery or stereotactic body radiotherapy (SBRT) treatment over 60 minutes. (completed as of 8-30-11) - Phase III: Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo 1 high-dose image-guided radiosurgery or SBRT treatment over 60 minutes. - Arm II: Patients undergo 1 standard-dose external beam radiotherapy treatment over 5 minutes. Patients undergo MRI of the treated spine at baseline and at 3, 6, 12, and 24 months*. Patients enrolled in the phase III portion also complete the Numerical Rating Pain Scale at baseline, at 1, 2, and 3 weeks after randomization, and at 1, 3, 6, 12, and 24 months. NOTE: *Patients enrolled in the phase II portion undergo MRI at baseline and at 3 months. After completion of study treatment, patients are followed up periodically.

Clinical Study Identifier: NCT00922974

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University of Colorado Cancer Center at UC Health Sciences Center
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Penrose Cancer Center at Penrose Hospital
Colorado Springs, CO United States
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George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, CT United States
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CCOP - Christiana Care Health Services
Newark, DE United States
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Baptist Cancer Institute - Jacksonville
Jacksonville, FL United States
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, IL United States
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Nguyet A. Le-Lindqwister

OSF St. Francis Medical Center
Peoria, IL United States
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Cancer Center at Ball Memorial Hospital
Muncie, IN United States
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Lucille P. Markey Cancer Center at University of Kentucky
Lexington, KY United States
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Shiao Y. Woo

James Graham Brown Cancer Center at University of Louisville
Louisville, KY United States
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Richard S. Hudes, MD

St. Agnes Hospital Cancer Center
Baltimore, MD United States
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Eleanor M. Walker, MD

Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, MI United States
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Gilbert D.A. Padula

Butterworth Hospital at Spectrum Health
Grand Rapids, MI United States
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William Beaumont Hospital - Royal Oak Campus
Royal Oak, MI United States
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Jeffrey Bradley, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, MO United States
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Billings Clinic - Downtown
Billings, MT United States
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Andrew O. Wahl

Nebraska Medical Center
Omaha, NE United States
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Su K. Metcalfe

Payson Center for Cancer Care at Concord Hospital
Concord, NH United States
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Arul Mahadevan

Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, NH United States
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Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, NH United States
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Shirnett K. Williamson, MD

Capital Health Regional Cancer Center
Pennington, NJ United States
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Stony Brook University Cancer Center
Stony Brook, NY United States
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Summa Center for Cancer Care at Akron City Hospital
Akron, OH United States
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Ohio State University Cancer Clinical ...

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, OH United States
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Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, PA United States
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Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, PA United States
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UPMC - Shadyside
Pittsburgh, PA United States
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UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, PA United States
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Paul B. Gilman, MD

Lankenau Cancer Center at Lankenau Hospital
Wynnewood, PA United States
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Michael J. Swartz

Rapid City Regional Hospital
Rapid City, SD United States
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Huntsman Cancer Institute at University of Utah
Salt Lake City, UT United States
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University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, WI United States
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Medical College of Wisconsin Cancer Center
Milwaukee, WI United States
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James H. Taylor, MD

All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, WI United States
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Shawn C. Malone

Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, ON Canada
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David Donath

Hopital Notre-Dame du CHUM
Montreal, QC Canada
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Jonathan F Wan

McGill Cancer Centre at McGill University
Montreal, QC Canada
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Benjamin W. Corn

Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
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