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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IITreatmentActive18 and overNCI, OtherRTOG-0631
CDR0000646803, NCI-2009-01687, NCT00922974

Trial Description

Summary

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)

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
  • NRG Oncology
Samuel Ryu, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

UAB Comprehensive Cancer Center

John Fiveash
Ph: 205-934-0309

California
La Jolla

Rebecca and John Moores UCSD Cancer Center

James D Murphy
Ph: 858-822-5354
Email: cancercto@ucsd.edu

Los Angeles

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Stephen L Shiao
Ph: 310-423-8965

Colorado
Colorado Springs

Penrose Cancer Center at Penrose Hospital

Alan T Monroe
Ph: 888-785-6789

Connecticut
New Britain

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

Neal B Goldberg
Ph: 860-224-5660

New Haven

Yale Cancer Center

Jonathan P. S. Knisely
Ph: 516-562-3467

Delaware
Newark

Helen F. Graham Cancer Center at Christiana Hospital

Adam Raben
Ph: 302-733-6227

Florida
The Villages

The Villages Regional Hospital

Sachin S Kamath
Ph: 352-751-8185

Illinois
Chicago

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

John A Kalapurakal
Ph: 312-695-1301
Email: cancer@northwestern.edu

Peoria

OSF St. Francis Medical Center

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Indiana
Indianapolis

Methodist Cancer Center at Methodist Hospital

Samuel Ryu

Iowa
Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Mark C Smith
Ph: 800-237-1225

Kentucky
Lexington

Central Baptist Hospital

Alan Beckman
Ph: 859-260-6425

University of Kentucky Chandler Medical Center

Ronald McGarry
Ph: 859-257-3379

Maryland
Baltimore

Greenebaum Cancer Center at University of Maryland Medical Center

Steven Feigenberg
Ph: 800-888-8823

St. Agnes Hospital Cancer Center

Richard S. Hudes
Ph: 410-368-2910

Massachusetts
Lowell

Lowell General Hospital

Matthew S Katz
Ph: 978-788-7084
Email: ghincks@lowellgeneral.org

Michigan
Detroit

Josephine Ford Cancer Center at Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

Wayne State University

Steven R. Miller
Ph: 313-576-9363

Farmington Hills

Weisberg Cancer Treatment Center

Andre A. Konski
Ph: 313-576-9363

Grand Rapids

Butterworth Hospital at Spectrum Health

Gilbert D Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Royal Oak

William Beaumont Hospital - Royal Oak Campus

Daniel J Krauss
Ph: 248-551-7695

West Bloomfield

Henry Ford Medical Center - West Bloomfield

Eleanor M. Walker
Ph: 313-916-1784

Montana
Billings

Billings Clinic Cancer Center - 801 N 29th Street

Benjamin Thomas Marchello
Ph: 800-648-6274

Nebraska
Omaha

Fred and Pamela Buffett Cancer Center

Andrew O Wahl
Ph: 402-559-6941
Email: unmcrsa@unmc.edu

New Hampshire
Dover

Seacoast Cancer Center at Wentworth - Douglass Hospital

Arul Mahadevan
Ph: 603-740-2150

Lebanon

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Alan C. Hartford
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New Jersey
Mount Laurel

Cooper CyberKnife Center

Tamara A LaCouture
Ph: 856-325-6757

Pennington

Capital Health Medical Center-Hopewell

Shirnett Karean Williamson
Ph: 800-255-3440

New York
Bronx

Montefiore Medical Center

Samuel Ryu

New Hyde Park

Monter Cancer Center of the North Shore-LIJ Health System

Jonathan P. S. Knisely
Ph: 516-562-3467

Stony Brook

Stony Brook University Cancer Center

Bong S Kim
Ph: 800-862-2215

North Carolina
Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

Hadley J Sharp
Ph: 704-355-2884

Winston-Salem

Wake Forest University Comprehensive Cancer Center

James J Urbanic
Ph: 858-822-5354
Email: cancercto@ucsd.edu

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Mitchell Lee Fromm
Ph: 330-344-6348

Summa Center for Cancer Care at Akron City Hospital

Charles A Kunos
Ph: 330-375-6101

Cleveland

Case Comprehensive Cancer Center

Samuel T Chao
Ph: 866-223-8100

Cleveland Clinic Taussig Cancer Center

Samuel T Chao
Ph: 866-223-8100

Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Samuel Ryu

Pennsylvania
Danville

Geisinger Cancer Institute at Geisinger Health

Thomas J Gergel
Ph: 570-271-5251

Pittsburgh

UPMC - Shadyside

Peter C Gerszten
Ph: 412-647-8073

Veterans Affairs Medical Center - Pittsburgh

Kristina Gerszten
Ph: 412-688-6104

South Dakota
Rapid City

Rapid City Regional Hospital

Michael J Swartz
Ph: 605-716-3982
Email: research@rcrh.org

Texas
Dallas

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Robert Dale Timmerman
Ph: 214-648-7097

Houston

Univeristy of Texas M.D. Anderson Cancer Center

Paul D. Brown
Ph: 713-792-3245

Utah
Salt Lake City

Huntsman Cancer Institute at University of Utah

Dennis C. Shrieve
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Wisconsin
Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Joseph A Bovi
Ph: 414-805-4380

Racine

All Saints Cancer Center at Wheaton Franciscan Healthcare

James H. Taylor
Ph: 414-874-4541
Email: Kelli.holton@wfhc.org

Canada

Ontario
Hamilton

Margaret and Charles Juravinski Cancer Centre

Anthony C Whitton
Ph: 905-387-9495

Quebec
Montreal

Hopital Notre-Dame du CHUM

David Donath
Ph: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

McGill Cancer Centre at McGill University

Neil Kopek
Ph: 514-934-1934ext42953
Email: evelyn.ortega@muhc.mcgill.ca

Israel

Petach Tikva

Rabin Medical Center - Beilinson Campus

Aaron M Allen
Ph: 888-823-5923
Email: ctsucontact@westat.com

Tel Aviv

Tel-Aviv Sourasky Medical Center

Andrew A Kanner
Ph: 011-972-3-6974761
Email: mop@tasmc.health.gov.il

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00922974
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.