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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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 RyuPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 John Fiveash Ph: 205-934-0309
California
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Daniel M. Chinn Ph: 925-674-2580
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
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Michael R Olson Ph: 904-202-7051
Hawaii
  Honolulu
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 John A Kalapurakal Ph: 312-695-1301
  Email: cancer@northwestern.edu
 Rush Cancer Institute at Rush University Medical Center
 Aidnag Zaid Diaz Ph: 210-450-3800
  Email: clinical_trials@rush.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
 University of Kentucky Chandler Medical Center
 Ronald McGarry Ph: 859-257-3379
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Aaron C Spalding Ph: 502-629-2500
Maryland
  Baltimore
 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
 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
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Daniel J Krauss Ph: 248-551-7695
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
Nebraska
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Andrew O Wahl Ph: 800-999-5465
New Hampshire
  Concord
 Payson Center for Cancer Care at Concord Hospital
 Su K Metcalfe Ph: 800-441-1138
  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
  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
 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
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Bethany M Anderson Ph: 877-405-6866
  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
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
  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 Identifer NCT00922974
ClinicalTrials.gov processed this data on October 20, 2014

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.

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