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

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI NCCTG-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

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

Outcomes

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

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: 507-284-2511
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

U.S.A.
Alabama
	Mobile
	Providence Cancer Center at Providence Hospital
		Paul Schwarzenberger, MD	Ph:  251-435-5892
California
	Auburn
	Auburn Radiation Oncology
		Anthony Pu, MD	Ph:  916-888-1266
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Anthony Pu, MD	Ph:  916-622-9700
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Anthony Pu, MD	Ph:  916-904-3440
	Roseville
	Radiation Oncology Center - Roseville
		Anthony Pu, MD	Ph:  916-969-4422
	Sacramento
	Mercy General Hospital
		Anthony Pu, MD	Ph:  916-453-4453
	Radiological Associates of Sacramento Medical Group, Incorporated
		Anthony Pu, MD	Ph:  916-646-8300
	Vacaville
	Solano Radiation Oncology Center
		Anthony Pu, MD	Ph:  707-447-0400
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-733-6227
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
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Jacksonville
	Baptist Cancer Institute - Jacksonville
		Clinical Trials Office - Baptist Cancer Institute - Jacksonville	Ph:  904-202-7051
Georgia
	Atlanta
	Saint Joseph's Hospital of Atlanta
		Clinical Trials Office - Saint Joseph's Hospital of Atlanta	Ph:  404-851-7115
Illinois
	Arlington Heights
	Northwest Community Hospital
		Stephen Nigh, MD	Ph:  847-618-6560
	Urbana
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		David Hornback, MD	Ph:  574-647-7461
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
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
Michigan
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
Minnesota
	Saint Cloud
	CentraCare Clinic - River Campus
		Harold Windschitl, MD	Ph:  320-252-5131
Nebraska
	Omaha
	Immanuel Medical Center
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
New Mexico
	Albuquerque
	Lovelace Medical Center - Downtown
		Benny Liem, MD	Ph:  505-727-8000
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Paul Okunieff, MD	Ph:  585-275-5345
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
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Akron
	Summa Center for Cancer Care at Akron City Hospital
		Clinical Trials Office - Akron City Hospital	Ph:  330-375-6101
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:  610-402-0500
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Pittsburgh
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		Judith Figura, MD	Ph:  412-578-1034
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Knoxville
	Thompson Cancer Survival Center
		Clinical Trials Office - Thompson Cancer Survival Center	Ph:  865-541-1812
Utah
	Salt Lake City
	LDS Hospital
		R. Jeffrey Lee, MD	Ph:  801-408-1146
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Jason Sheehan	Ph:  434-924-9333 800-223-9173
Canada
Ontario
	Toronto
	Princess Margaret Hospital
		Cynthia Menard	Ph:  416-946-2811
Quebec
	Sherbrooke
	CHUS-Hopital Fleurimont
		Abdenour Nabid, MD, FRCPC	Ph:  819-346-1110

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		2008-10-09
NCI Grant/Contract Number		CA25224