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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase III, Phase IITreatment18 and overRTOG 0631
NCI-2009-01687, CDR0000646803, NCT00922974

Trial Description

Summary

This partially randomized phase II/III trial studies how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with cancer that has spread locally to the spine (localized spine metastasis). Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells, cause less damage to normal tissue, and may reduce spinal pain. It is not yet known whether radiosurgery or stereotactic body radiation therapy is more effective than external-beam radiation therapy in treating localized spine metastasis.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine the feasibility of successfully delivering image-guided radiosurgery/stereotactic body radiation therapy (SBRT) for spine metastases in a cooperative group setting. (Phase II)

II. Determine whether image-guided radiosurgery/SBRT (single dose of 16 or 18 Gray [Gy]) improves pain control (as measured by the 11-point Numerical Rating Pain Scale [NRPS]) as compared to conventional external beam radiotherapy (single dose of 8 Gy). (Phase III)

SECONDARY OBJECTIVES:

I. Determine whether image-guided radiosurgery/SBRT improves the rapidity of pain response at the treated site(s) as compared to conventional external beam radiotherapy, as measured by the NRPS. (Phase III)

II. Determine whether image-guided radiosurgery/SBRT increases the duration of pain response at the treated site(s), as compared to conventional external beam radiotherapy, as measured by the NRPS. (Phase III)

III. Compare adverse events between the two treatments according to the criteria in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (Phase III)

IV. Evaluate the long-term effects (24 months) of image-guided radiosurgery/SBRT on the vertebral bone (such as compression fracture) and the spinal cord by magnetic resonance imaging (MRI). (Phase III)

V. Evaluate the potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G); in pain as measured by the Brief Pain Inventory (BPI); and in health utilities as measured by the EuroQol (European Quality of Life 5-Dimensions [EQ-5D]). (Phase III)

VI. To implement a well-controlled specimen handling/storage process to facilitate future laboratory correlative studies. (Phase III)

OUTLINE: This is a phase II study followed by a randomized phase III study.

PHASE II: Patients undergo 1 high-dose image-guided radiosurgery or SBRT treatment over 60 minutes.

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.

After completion of study treatment, patients are followed up at 1, 3, 6, 12, and 24 months.

Eligibility Criteria

Inclusion Criteria:

The patient must have localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels by a screening imaging study (bone scan, positron emission tomography [PET], computed tomography [CT], or MRI) (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites [e.g., C5, thoracic (T)5-6, and T12] are permitted;) each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies; patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible

Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control

Zubrod performance status 0-2

Eligible metastatic lesions: 1) a solitary spine metastasis; 2) two contiguous spine levels involved; or 3) a maximum of 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies; epidural compression (arrow) is eligible when there is a >= 3 mm gap between the spinal cord and the edge of the epidural lesion; a paraspinal mass =< 5 cm is allowed

History/physical examination within 2 weeks prior to registration

Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential

Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; patients with mild to moderate neurological signs are eligible; these neurological signs include 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)

Patients with epidural compression are eligible provided that there is a >= 3 mm gap between the spinal cord and the edge of the epidural lesion

Patients with a paraspinal mass =< 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible

Patients must provide study specific informed consent prior to study entry

There can be multiple small metastatic lesions shown in other vertebral bodies; the metastatic lesion of each spine should be less than 20% of the vertebral body as opposed to the diffuse vertebral involvement; these small lesions are often seen in the MRI even when bone scan or PET was negative; most of these lesions are not clinically required to be treated and are therefore not included in the target volume of this protocol; only the painful spine (pain score >= 5) is to be treated

MRI (contrast is not required but strongly recommended) of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement; an MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component; note: if an MRI was done as a screening imaging study for eligibility, the MRI can be used as the required MRI for treatment planning

Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the scale of >= 5 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

Exclusion Criteria:

Histologies of myeloma or lymphoma

Patients allergic to contrast dye used in MRIs or CT scans or who cannot be premedicated for the use of contrast dye

> 50% loss of vertebral body height

Bony retropulsion causing neurologic abnormality

Patients for whom an MRI of the spine is medically contraindicated

Non-ambulatory patients

Spine instability due to a compression fracture

Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord

Patients with rapid neurologic decline

Prior radiation to the index spine

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Samuel Ryu, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

University of Alabama at Birmingham Cancer Center

John B. Fiveash
Ph: 205-934-0309

John B. Fiveash
Principal Investigator

California
La Jolla

UC San Diego Moores Cancer Center

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

James D. Murphy
Principal Investigator

Connecticut
New Britain

The Hospital of Central Connecticut

Neal B. Goldberg
Ph: 860-224-5660

Neal B. Goldberg
Principal Investigator

New Haven

Yale University

Jonathan Petrus Sandberg Knisely
Ph: 516-562-3467

Jonathan Petrus Sandberg Knisely
Principal Investigator

Illinois
Chicago

Northwestern University

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

John Andrew Kalapurakal
Principal Investigator

Peoria

OSF Saint Francis Medical Center

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

Nguyet Anh Le-Lindqwister
Principal Investigator

Indiana
Fort Wayne

Parkview Hospital Randallia

Brian K. Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Brian K. Chang
Principal Investigator

Indianapolis

IU Health Methodist Hospital

Samuel Ryu

Samuel Ryu
Principal Investigator

Kentucky
Lexington

Baptist Health Lexington

Alan Beckman
Ph: 859-260-6425

Alan Beckman
Principal Investigator

Maryland
Baltimore

University of Maryland/Greenebaum Cancer Center

Steven J. Feigenberg
Ph: 800-888-8823

Steven J. Feigenberg
Principal Investigator

Bel Air

Upper Chesapeake Medical Center

Steven J. Feigenberg
Ph: 800-888-8823

Steven J. Feigenberg
Principal Investigator

Massachusetts
Lowell

Lowell General Hospital

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

Matthew Strauss Katz
Principal Investigator

Michigan
Detroit

Henry Ford Hospital

Eleanor M. Walker
Ph: 313-916-1784

Eleanor M. Walker
Principal Investigator

Flint

McLaren-Flint

Kiran Devisetty
Ph: 989-667-6257

Kiran Devisetty
Principal Investigator

Grand Rapids

Spectrum Health at Butterworth Campus

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

Gilbert D.A. Padula
Principal Investigator

West Bloomfield

Henry Ford Medical Center - West Bloomfield

Eleanor M. Walker
Ph: 313-916-1784

Eleanor M. Walker
Principal Investigator

Montana
Billings

Billings Clinic Cancer Center

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Nebraska
Omaha

University of Nebraska Medical Center

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

Andrew Owen Wahl
Principal Investigator

New Hampshire
Dover

Wentworth-Douglass Hospital

Arul Mahadevan
Ph: 603-740-2150

Arul Mahadevan
Principal Investigator

Lebanon

Dartmouth Hitchcock Medical Center

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

Alan Charles Hartford
Principal Investigator

New Jersey
Mount Laurel

Cooper CyberKnife Center

Tamara Anne LaCouture
Ph: 856-325-6757

Tamara Anne LaCouture
Principal Investigator

Pennington

Capital Health Medical Center-Hopewell

Shirnett Karean Williamson
Ph: 800-255-3440

Shirnett Karean Williamson
Principal Investigator

New York
Bronx

Montefiore Medical Center - Moses Campus

Samuel Ryu

Samuel Ryu
Principal Investigator

New Hyde Park

North Shore-LIJ Health System/Center for Advanced Medicine

Jonathan Petrus Sandberg Knisely
Ph: 516-562-3467

Jonathan Petrus Sandberg Knisely
Principal Investigator

Stony Brook

Stony Brook University Medical Center

Bong Soon Kim
Ph: 800-862-2215

Bong Soon Kim
Principal Investigator

North Carolina
Charlotte

Carolinas Medical Center/Levine Cancer Institute

Hadley J. Sharp
Ph: 704-355-2884

Hadley J. Sharp
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

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

James John Urbanic
Principal Investigator

Ohio
Akron

Akron General Medical Center

Mitchel L. Fromm
Ph: 330-344-6348

Mitchel L. Fromm
Principal Investigator

Summa Akron City Hospital/Cooper Cancer Center

Charles Andrew Kunos
Ph: 330-375-6101

Charles Andrew Kunos
Principal Investigator

Cincinnati

University of Cincinnati

Kevin Patrick Redmond
Ph: 513-558-4553
Email: uchealthnews@uc.edu

Kevin Patrick Redmond
Principal Investigator

Columbus

Ohio State University Comprehensive Cancer Center

Samuel Ryu

Samuel Ryu
Principal Investigator

Pennsylvania
Danville

Geisinger Medical Center

Thomas James Gergel
Ph: 570-271-5251

Thomas James Gergel
Principal Investigator

South Dakota
Rapid City

Rapid City Regional Hospital

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

Michael J. Swartz
Principal Investigator

Texas
Austin

University Medical Center Brackenridge

Ahmad Paiman Ghafoori
Ph: 512-324-7991

Ahmad Paiman Ghafoori
Principal Investigator

Houston

M D Anderson Cancer Center

Paul D. Brown
Ph: 713-792-3245

Paul D. Brown
Principal Investigator

Utah
Salt Lake City

Huntsman Cancer Institute/University of Utah

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

Dennis Charles Shrieve
Principal Investigator

Wisconsin
Milwaukee

Froedtert and the Medical College of Wisconsin

Joseph A. Bovi
Ph: 414-805-4380

Joseph A. Bovi
Principal Investigator

Racine

Wheaton Franciscan Cancer Care - All Saints

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

James H. Taylor
Principal Investigator

Canada

Quebec
Montreal

CHUM - Hopital Notre-Dame

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

David Donath
Principal Investigator

Israel

Petach Tikva

Rabin Medical Center

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

Aaron Max Allen
Principal Investigator

Tel Aviv

Tel Aviv Sourasky Medical Center

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

Andrew A. Kanner
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00922974

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.