Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases

Metastatic Cancer Clinical Trial

Official title:

A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002708
• Other study ID #: RTOG-9508
• Secondary ID: CDR0000064522
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: November 18, 2013
• Start date: January 1996
• Est. completion date: December 2004

Study information

• Verified date: November 2013
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery.

Description:

OBJECTIVES: I. Compare the overall survival of patients with one unresected brain metastasis treated with conventional whole brain radiotherapy (WBRT) with vs. without a stereotactic radiosurgery (SRS) boost. II. Compare sites of recurrence and cause of death in these patients treated with WBRT followed by SRS vs. WBRT alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and extracranial disease (yes or no). Patients are randomized to one of two treatment arms. Arm I: Patients receive fractionated external beam whole brain irradiation (WBRT) 5 days each week for 3 weeks. Both portals are treated during each radiotherapy session. Patients who still have a solitary lesion with a diameter no greater than 4.0 cm also receive stereotactic radiosurgery within 7 days of completing WBRT. Arm II: Patients receive WBRT only. Patients are followed every 3 months for 1 year, then every 4 months for 2 years, and then annually.

PROJECTED ACCRUAL: A total of 262 patients will be accrued over 2.5-3.75 years for this study. The study may close early if interim analysis after 33% and 67% of patients have been followed for 6 months produces significant results. After 6/14/99 an additional 46 patients with a solitary brain metastasis only will be accrued.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 2004
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: No more than 1 unresected or subtotally resected brain metastasis lesion from histologically confirmed systemic malignancy Eligible only if surgical resection refused by patient or resection deemed inappropriate by patient's physician 1 intraparenchymal metastasis clearly defined on contrast enhanced MRI Maximum diameter of lesion no greater than 4.0 cm No leukemia or lymphoma Extracranial sites of primary metastatic disease allowed if no clinical or radiographic evidence of progression within 1 month prior to entry No metastasis to brainstem, midbrain, pons, or medulla No leptomeningeal metastasis by MRI or CSF evaluation No metastasis within 10 mm of optic nerves and chiasm (area must be excluded from high dose stereotactic radiosurgery boost field)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 70-100% Karnofsky Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Not specified Renal: Not specified Other: Neurologic status 0-2 No major medical or psychiatric contraindication to protocol entry Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy for systemic cancer Endocrine therapy: Concurrent hormonal therapy, including tamoxifen, allowed Radiotherapy: No prior cranial radiotherapy Surgery: Prior subtotal resection allowed Other: No other concurrent treatment for brain metastasis until recurrence

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• surgical procedure

Radiation:
• radiation therapy

• stereotactic radiosurgery

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Centre Universitaire de Sante de l'Estrie - Site Fleurimont	Fleurimont	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	McGill University Department of Oncology	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre - General Campus	Ottawa	Ontario
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	BC Cancer Agency	Vancouver	British Columbia
United States	Akron City Hospital	Akron	Ohio
United States	Akron General Medical Center	Akron	Ohio
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Saint Joseph Medical Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Harrington Cancer Center	Amarillo	Texas
United States	Providence Cancer Therapy Center	Anchorage	Alaska
United States	St. John's Medical Center	Anderson	Indiana
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Anne Arundel Oncology Center	Annapolis	Maryland
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Greater Baltimore Medical Center and Cancer Center	Baltimore	Maryland
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Radiation Oncology Affiliates of Maryland, P.A.	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Julie and Ben Rogers Cancer Institute	Beaumont	Texas
United States	CCOP - Southwestern Vermont Regional Cancer Center	Bennington	Vermont
United States	St. Luke's Hospital Regional Cancer Center	Bethlehem	Pennsylvania
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	New York Methodist Hospital	Brooklyn	New York
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Cooper Cancer Institute	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center, University of Virginia HSC	Charlottesville	Virginia
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	Lykes Center for Radiation Therapy	Clearwater	Florida
United States	Ireland Cancer Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Finger Lakes Radiation Oncology, P.C.	Clifton Springs	New York
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Medical Center/John B. Amos Community Cancer Center	Columbus	Georgia
United States	Mount Diablo Medical Center	Concord	California
United States	Northeast Medical Center	Concord	North Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Catholic Medical Center, Mercy Fitzgerald Divison	Darby	Pennsylvania
United States	Halifax Medical Center	Daytona Beach	Florida
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Wendt Regional Cancer Center of Finley Hospital	Dubuque	Iowa
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Provena St. Joseph Hospital- Regional Cancer Care Center	Elgin	Illinois
United States	Trinitas Hospital - Jersey Street Campus	Elizabeth	New Jersey
United States	Meritcare Roger Maris Cancer Center	Fargo	North Dakota
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Regional Cancer Center	Flint	Michigan
United States	Radiation Therapy Associates - Fort Myers	Fort Myers	Florida
United States	California Cancer Center	Fresno	California
United States	Saint Agnes Cancer Center	Fresno	California
United States	University of Florida Health Science Center	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Glendale Memorial Hospital and Health Center	Glendale	California
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Sutter Health Western Division Cancer Research Group	Greenbrae	California
United States	CCOP - Greenville	Greenville	South Carolina
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	RMH Regional Canter Center	Harrisonburg	Virginia
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Penn State Geisinger Cancer Center	Hershey	Pennsylvania
United States	Catawba Memorial Hospital	Hickory	North Carolina
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Institute of Huntsville	Huntsville	Alabama
United States	Huntsville Hospital System	Huntsville	Alabama
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Clarion Health Partners Inc.	Indianapolis	Indiana
United States	Community Hospitals of Indianapolis - Regional Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Dayton	Kettering	Ohio
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Gundersen Lutheran Medical Foundation	La Crosse	Wisconsin
United States	University of California San Diego Cancer Center	La Jolla	California
United States	Wilford Hall - 59th Medical Wing	Lackland Air Force Base	Texas
United States	Romagosa Radiation Oncology Center	Lafayette	Louisiana
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Beckman Research Institute, City of Hope	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Louisville Radiation Oncology	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Virginia Baptist Hospital	Lynchburg	Virginia
United States	Southern Wisconsin Radiotherapy Center	Madison	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Merle M. Mahr Cancer Center	Madisonville	Kentucky
United States	Elliot Regional Cancer Center	Manchester	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Marquette General Hospital	Marquette	Michigan
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Health First Holmes Regional Medical Center	Melbourne	Florida
United States	CCOP - Baptist Cancer Institute	Memphis	Tennessee
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee
United States	Community Memorial Hospital	Menomonee Falls	Wisconsin
United States	Baptist Hospital of Miami	Miami	Florida
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Veterans Affairs Medical Center - Miami	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MidMichigan Medical Center - Midland	Midland	Michigan
United States	South Jersey Hospital - Millville	Millville	New Jersey
United States	Columbia Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	St. Joseph's Hospital	Milwaukee	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	UNIMED Medical Center	Minot	North Dakota
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Urology Associates - Mobile AL	Mobile	Alabama
United States	Alabama Oncology, LLC	Montgomery	Alabama
United States	Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County	Mount Holly	New Jersey
United States	Ball Memorial Hospital	Muncie	Indiana
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Whittingham Cancer Center	Norwalk	Connecticut
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	St. Anthony Hospital	Oklahoma City	Oklahoma
United States	Methodist Cancer Center - Omaha	Omaha	Nebraska
United States	Nebraska Health System	Omaha	Nebraska
United States	Florida Radiation Oncology Group	Orange Park	Florida
United States	MD Anderson Cancer Center Orlando	Orlando	Florida
United States	Western Baptist Hospital	Paducah	Kentucky
United States	Bay Medical Center	Panama City	Florida
United States	Gulf Coast Cancer Treatment Center	Panama City	Florida
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Bayshore Medical Center	Pasadena	Texas
United States	West Florida Cancer Institute - Pensacola	Pensacola	Florida
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Veterans Affairs Medical Center - Philadelphia	Philadelphia	Pennsylvania
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Champlain Valley Physicians Hospital Medical Center	Plattsburgh	New York
United States	Atlantic City Medical Center	Pomona	New Jersey
United States	Cancer Care Center	Pomona	California
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Maine Medical Center	Portland	Maine
United States	Naval Medical Center, Portsmouth	Portsmouth	Virginia
United States	Vassar Brothers Hospital	Poughkeepsie	New York
United States	Roger Williams Medical Center/BUSM	Providence	Rhode Island
United States	Southeastern Wisconsin Regional Cancer Center	Racine	Wisconsin
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University of Rochester Cancer Center	Rochester	New York
United States	InterCommunity Cancer Center at Rome	Rome	Georgia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Green Mountain Oncology Group	Rutland	Vermont
United States	Radiation Oncology Center - Sacramento	Sacramento	California
United States	St. Mary's Medical Center	Saginaw	Michigan
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Mallinckrodt Institute of Radiology	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Radiation Medical Group, Inc.	San Diego	California
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	O'Connor Hospital	San Jose	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Sarasota Radiation and Medical Oncology Center	Sarasota	Florida
United States	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania
United States	Swedish Cancer Institute	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	St. Joseph's Radiation Oncology Center	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Deaconess Medical Center	Spokane	Washington
United States	Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Stanford University	Stanford	California
United States	Tallahassee Memorial Healthcare	Tallahassee	Florida
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio
United States	Community Medical Center	Toms River	New Jersey
United States	St. Francis Medical Center	Trenton	New Jersey
United States	Arizona Cancer Center	Tucson	Arizona
United States	St. John Medical Center	Tulsa	Oklahoma
United States	North Mississippi Medical Center/Cancer Center	Tupelo	Mississippi
United States	Radiation Oncology Associates of West Alabama	Tuscallosa	Alabama
United States	East Texas Medical Center - Cancer Institute	Tyler	Texas
United States	New York Medical College	Valhalla	New York
United States	Associated Radiologists, P.A.	Warren	New Jersey
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Schiffler Cancer Center	Wheeling	West Virginia
United States	Wilkes Barre General Hospital	Wilkes-Barre	Pennsylvania
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Yakima Valley Memorial Hospital	Yakima	Washington
United States	York Hospital	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with o — View Citation

Hazard LJ, Jensen RL, Shrieve DC. Role of stereotactic radiosurgery in the treatment of brain metastases. Am J Clin Oncol. 2005 Aug;28(4):403-10. Review. — View Citation

Sperduto P, Scott C, Andrews D, et al.: Preliminary report of RTOG 95-08: a phase III trial comparing whole brain irradiation alone versus whole brain irradiation plus stereotactic radiosurgery for patients with two or three unresected brain metastases. [

Sperduto PW, Scott C, Andrews D: Stereotactic radiosurgery with whole brain radiation therapy improves survival in patients with brain metastases: report of Radiation Therapy Oncology Group phase III study 95-08. [Abstract] Int J Radiat Oncol Biol Phys 54