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Last Modified: 11/15/2009     First Published: 9/10/2006  
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Phase III Randomized Study of Stereotactic Radiosurgery With Versus Without Whole-Brain Radiotherapy in Patients With Cerebral Metastases

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCINCCTG-N0574
N0574, ACOSOG-N0574, NCT00377156

Special Category: NCI Web site featured trial, CTSU trial

Objectives

Primary

  1. Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy.

Secondary

  1. Compare time to CNS (brain) failure in patients treated with these regimens.
  2. Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens.
  3. Compare post-treatment toxicity in these patients.

Entry Criteria

Disease Characteristics:

  • Diagnosis of cerebral metastases meeting the following criteria:
    • One to three presumed brain metastases
    • Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)
      • Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s)
    • Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days
    • Lesions must not be within 5 mm of the optic chiasm or within the brainstem

  • Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist

  • No primary germ cell tumor, small cell carcinoma, or lymphoma

  • No leptomeningeal metastases

  • No clinical or radiographic evidence of systemic progression (other than the study lesion[s]) within the past month

  • Hormone receptor status not specified

Prior/Concurrent Therapy:

  • More than 7 days since prior and no concurrent chemotherapy
  • No prior cranial radiotherapy
  • No prior resection of cerebral metastases
  • Concurrent hormonal agents, steroids, and/or anticonvulsants allowed

Patient Characteristics:

  • Male or female
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
    • Male patients must continue to use contraception for 3 months after the completion of radiotherapy
  • No pacemaker or other MRI-incompatible metal in the body
  • No known allergy to gadolinium

Expected Enrollment

528

A total of 528 patients will be accrued for this protocol.

Outcomes

Primary Outcome(s)

Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months

Secondary Outcome(s)

Time to CNS failure
Quality of life, in terms of brain subscale and physical and emotional functioning, as measured by FACT-BR questionnaire, physician-assessed neurological signs and symptoms, and treatment-related adverse events at 3 months post treatment
Functional independence as measured by Barthel Activities of Daily Living Index and ECOG performance status
Duration of functional independence
Neurocognitive status as measured by objective assessment of changes in cognitive signs and symptoms and physician-assessed toxicities at 3 months post treatment

Outline

This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for > 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo stereotactic radiosurgery (SRS).

  • Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Paul Brown, MD, Protocol chair
Ph: 507-284-2949
Kurt Jaeckle, MD, Protocol co-chair
Ph: 904-953-7102
Richard Deming, MD, Protocol co-chair
Ph: 515-643-8780
Email: rdeming@mercydesmoines.org
Elana Farace, PhD, Protocol co-chair
Ph: 717-531-7386
Bruce Pollock, MD, Protocol co-chair
Ph: 507-284-2511

American College of Surgeons Oncology Group

Anthony Asher, MD, FACS, Protocol chair
Ph: 704-376-1605; 800-344-6716
Email: tony.asher@cnsa.com
Fred Barker, MD, Protocol co-chair
Ph: 617-724-8772 ; 877-726-5130

Eastern Cooperative Oncology Group

Larry Kleinberg, MD, Protocol chair
Ph: 410-614-2497
Email: kleinla@jhmi.edu

Radiation Therapy Oncology Group

Anthony Asher, MD, FACS, Protocol chair
Ph: 704-376-1605; 800-344-6716
Email: tony.asher@cnsa.com

Trial Sites

U.S.A.
Alabama
  Mobile
 Providence Cancer Center at Providence Hospital
 Thaddeus Beeker
Ph: 251-633-1890
Arizona
  Phoenix
 Arizona Oncology Services Foundation
 David Brachman, MD, FACRO
Ph: 602-274-4484
California
  Modesto
 Memorial Medical Center
 Clinical Trials Office - Memorial Medical Center
Ph: 209-572-7116
  Rancho Mirage
 Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
 Monica Khanna
Ph: 760-674-3600
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Clinical Trials Office - University of Colorado Cancer Center
Ph: 720-848-0650
Florida
  Boca Raton
 Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
 Clinical Trials Office - Eugene M. and Christine E. Lynn Cancer Institute
Ph: 561-955-4800
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Clinical Trials Office - Baptist Cancer Institute - Jacksonville
Ph: 904-202-7051
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Georgia
  Atlanta
 Northside Hospital Cancer Center
 Clinical Trials Office - Northside Hospital Cancer Center
Ph: 404-303-3355
 Saint Joseph's Hospital of Atlanta
 Clinical Trials Office - Saint Joseph's Hospital of Atlanta
Ph: 404-851-7115
Indiana
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian Chang
Ph: 260-373-7850
Iowa
  Des Moines
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert Behrens
Ph: 515-643-8206
888-221-4849
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Ph: 913-588-4709
Michigan
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus
Ph: 248-551-7695
Minnesota
  Duluth
 CCOP - Duluth
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - River Campus
 Barbi Kaplan-Frenkel, DO
Ph: 320-229-4901
Nebraska
  Omaha
 Immanuel Medical Center
 Gamini Soori, MD, FACP, FRCP, MBA
Ph: 402-393-3110
New Hampshire
  Dover
 Seacoast Cancer Center at Wentworth - Douglass Hospital
 Arul Mahadevan
Ph: 603-230-6100
  Manchester
 Elliot Regional Cancer Center at Elliot Hospital
 Andrea McKee, MD
Ph: 603-663-1800
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
  Greenville
 Leo W. Jenkins Cancer Center at ECU Medical School
 Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU Medical School
Ph: 252-744-2391
  Winston-Salem
 Forsyth Regional Cancer Center at Forsyth Medical Center
 Clinical Trials Office - Forsyth Regional Cancer Center at Forsyth Medical Center
Ph: 336-277-8887
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
  Salem
 Cancer Care Center, Incorporated
 William Demas, MD
Ph: 330-375-3557
  Wooster
 Cancer Treatment Center
 Clinical Trials Office - Cancer Treatment Center
Ph: 330-375-4221
 Cleveland Clinic - Wooster
 Clinical Trials Office - Cleveland Clinic - Wooster
Ph: 800-862-7798
Oklahoma
  Tulsa
 Natalie Warren Bryant Cancer Center at St. Francis Hospital
 Mark Olsen, MD, PhD
Ph: 918-499-2000
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Suresh Nair, MD
Ph: 610-402-0512
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  Pittsburgh
 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
 Judith Figura, MD
Ph: 412-578-1923
Rhode Island
  Providence
 Rhode Island Hospital Comprehensive Cancer Center
 Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center
Ph: 401-444-1488
South Carolina
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Utah
  Salt Lake City
 LDS Hospital
 R. Jeffrey Lee, MD
Ph: 801-408-1146
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Gerald Lim
Ph: 403-521-3701
Ontario
  Toronto
 Princess Margaret Hospital
 Cynthia Menard
Ph: 416-946-2811
Quebec
  Sherbrooke
 CHUS-Hopital Fleurimont
 Abdenour Nabid, MD, FRCPC
Ph: 819-346-1110ext.14602

Related Information

Featured trial article
PDQ® clinical trial ACOSOG-Z0300

Registry Information
Official Title Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases
Trial Start Date 2006-07-28
Trial Completion Date 2011-07-02 (estimated)
Registered in ClinicalTrials.gov NCT00377156
Date Submitted to PDQ 2006-07-14
Information Last Verified 2009-11-15
NCI Grant/Contract Number CA25224

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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