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



Status:Active, not recruiting
Conditions:Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - 120
Updated:4/17/2018
Start Date:November 2009
End Date:January 2022

Use our guide to learn which trials are right for you!

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

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)

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.

DISEASE CHARACTERISTICS:

- Diagnosis of localized spine metastasis at the C1 to L5 levels by a screening imaging
study (bone scan, PET, CT, or MRI), meeting any of the following criteria:

- Solitary spine metastasis

- Two contiguous spine levels involved

- No more than 3 separate sites (e.g., C5, T5-6, and T12) involved

- No more than 2 contiguous vertebral bodies involved at each separate site

- Other visceral metastasis, and radioresistant tumors (including soft tissue
sarcomas, melanomas, and renal cell carcinomas) are eligible

- No myeloma or lymphoma

- Epidural compression allowed provided there is ≥ 3 mm gap between the spinal cord and
edge of epidural lesion

- Paraspinal mass allowed provided it is ≤ 5 cm in the greatest dimension and contiguous
with spine metastasis

- Has undergone MRI of the involved spine within the past 4 weeks to determine the
extent of spine involvement

- No spine metastasis that is not planned to be treated per protocol

- No rapid neurologic decline

- Mild to moderate neurological signs, including radiculopathy, dermatomal sensory
change, and muscle strength of involved extremity 4/5 (lower extremity for
ambulation or upper extremity for raising arms and/or arm function), allowed

- No spine instability due to compression fracture, frank spinal cord compression or
displacement, or epidural compression within 3 mm of the spinal cord

- No more than 50% loss of vertebral body height

- No bony retropulsion causing neurologic abnormality

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be ambulatory

- No medical contraindications to an MRI of the spine

- No allergy to contrast dye used in MRI or CT scans

- The patient must have a score on the Numerical Rating Pain Scale of ≥ 5 within 1 week
prior to registration for at least one of the planned sites for spine radiosurgery

- Documentation of the patient's initial pain score is required

- Patients taking medication for pain at the time of registration are eligible

PRIOR CONCURRENT THERAPY:

- Concurrent pain medication allowed

- No prior radiotherapy to the index spine

- No chemotherapy for ≥ 24 hours before, during, and for ≥ 24 hours after completion of
radiosurgery
We found this trial at
35
sites
100 Grand Street
New Britain, Connecticut 06050
(860) 224-5299
Phone: 860-224-5660
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus The...
?
mi
from
New Britain, CT
Click here to add this to my saved trials
675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Phone: 312-695-1301
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
500 University Drive
Hershey, Pennsylvania 17033
(717) 531-8521
Phone: 717-531-3779
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
?
mi
from
Hershey, PA
Click here to add this to my saved trials
One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Phone: 603-650-7609
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
800 Rose St
Lexington, Kentucky 40536
(859) 257-4488
Phone: 859-257-3379
Lucille P. Markey Cancer Center at University of Kentucky The Markey Cancer Center was founded...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
161 North Forge Street
Akron, Ohio 44304
(330) 375-7280
Phone: 330-375-6101
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
?
mi
from
Akron, OH
Click here to add this to my saved trials
Aurora, Colorado 80045
Phone: 720-848-0650
?
mi
from
Aurora, CO
Click here to add this to my saved trials
900 Caton Ave.
Baltimore, Maryland 21229
410-368-6000
Phone: 410-368-2965
St. Agnes Hospital Cancer Center Saint Agnes Hospital is leading Maryland in the battle against...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Billings, Montana 59107
Phone: 800-996-2663
?
mi
from
Billings, MT
Click here to add this to my saved trials
2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
(719) 776-5000
Phone: 719-776-5275
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, New Hampshire 03301
Phone: 603-225-2711
?
mi
from
Concord, NH
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(888) 777-4167
Phone: 313-916-1021
Josephine Ford Cancer Center at Henry Ford Hospital A diagnosis of cancer is one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Dover, New Hampshire 03820
Phone: 603-742-8787
?
mi
from
Dover, NH
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
Phone: 616-391-2799
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
800 Prudential Drive
Jacksonville, Florida 32207
904.202.2000
Phone: 904-202-7051
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 502-562-4158
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53792
Phone: 608-262-5223
?
mi
from
Madison, WI
Click here to add this to my saved trials
8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
(414) 805-6840
Phone: 414-805-4380
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Muncie, Indiana 47303
Phone: 765-281-2107
?
mi
from
Muncie, IN
Click here to add this to my saved trials
4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
?
mi
from
Newark, DE
Click here to add this to my saved trials
4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
Phone: 402-552-2000
Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Ottawa, Ontario
Phone: 613-737-7700 ext. 70209
?
mi
from
Ottawa,
Click here to add this to my saved trials
Pennington, New Jersey 08534
Phone: 340-775-5433
?
mi
from
Pennington, NJ
Click here to add this to my saved trials
530 NE Glen Oak Ave
Peoria, Illinois 61637
(309) 655-2000
Phone: 309-655-2000
OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Phone: 215-955-6084
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Phone: 412-621-2334
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Phone: 412-647-2811
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Racine, Wisconsin 53405
Phone: 262-687-5000
?
mi
from
Racine, WI
Click here to add this to my saved trials
353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Phone: 605-719-2360
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Royal Oak, Michigan 48073
Phone: 248-551-7695
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-362-8525
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Phone: 801-581-4477
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
(631) 638-1000
Phone: 800-862-2215
Stony Brook University Cancer Center Ask a cancer survivor. Having highly advanced care close to...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
(484) 476-2000
Phone: 610-645-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials