Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Successful delivery of image-guided radiosurgery or stereotactic body radiotherapy in the Radiation Therapy Oncology Group (RTOG) cooperative group setting (Phase II)
End of protocol treatment
No
Samuel Ryu, MD
Principal Investigator
Josephine Ford Cancer Center at Henry Ford Hospital
United States: Federal Government
RTOG-0631
NCT00922974
November 2009
Name | Location |
---|---|
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
UPMC Cancer Center at UPMC Presbyterian | Pittsburgh, Pennsylvania 15213 |
UPMC - Shadyside | Pittsburgh, Pennsylvania 15213-2582 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Capital Health Regional Cancer Center | Trenton, New Jersey 08618 |
Payson Center for Cancer Care at Concord Hospital | Concord, New Hampshire 03301 |
Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover, New Hampshire 03820 |
Nebraska Medical Center | Omaha, Nebraska 68198 |