Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

368

Participants

Timeline

Start Date

February 29, 2004

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2007

Conditions
Breast CancerMetastases
Interventions
DRUG

Efaproxiral

"75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).~Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days."

RADIATION

Whole Brain Radiation Therapy (WBRT)

3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.

OTHER

Supplemental Oxygen

"4 L/minute by nasal cannula.~Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days."

Trial Locations (94)

4

Clinical Hospital Osijek, Osijek

11

Hospital Edgardo Rebagliati Martins (ESSALUD), Lima

27

Radiooncologia, Radiation Oncology Center, Lima

34

Instituto de Enfermedades Neoplasicas (INEN), Lima

197

University Hospital for Tumors, Zagreb

2000

Centro de Terapia Radiante Cumbres (CAICI), Rosario

4032

University of Debrecen, Debrecen

6020

Medical University Innsbruck, Innsbruck

8035

Ciutat Sanitari de Vall d'Hebron, Barcelona

10000

CHU Zagreb University School of Medicine, Zagreb

10469

Eastchester Center for Cancer Care, The Bronx

11203

SUNY Downstate Medical Center, Brooklyn

14226

Dent Neurologic Institute, Amherst

19107

Thomas Jefferson University, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20817

Center for Cancer and Blood Disorders, Bethesda

21079

Centre Georges François Leclerc, Dijon

21231

Johns Hopkins Oncology Center, Baltimore

21236

Maryland Hematology Oncology, Baltimore

21237

Franklin Square Hospital Center, Baltimore

22015

Clinique Armoricaine de, Saint-Brieuc

25209

Hopital de Montbeliard, Montbéliard

27599

University of North Carolina Breast Center, Chapel Hill

27710

Duke University Medical Center, Durham

28034

Hospital Ramon Y Cajal, Madrid

28100

Azienda Ospedaliera Maggiore della Carita, Novara

30322

Emory University Winship Cancer Institute, Atlanta

31008

Clinica Universitaria de Navarra, Pamplona

33136

University of Miami Medical, Miami

33486

Boca Raton Community Hospital, Boca Raton

33612

University of South Florida - H. Lee Moffitt Cancer Center, Tampa

43210

Ohio State University, Columbus

44195

Cleveland Clinic Hospital, Cleveland

45267

University of Cincinnati Division of Hematology-Oncology, Cincinnati

46009

Instituto Valenciano de Oncologia, Valencia

46204

Indiana University School of Medicine, Indianapolis

46805

Parkview Research Center, Fort Wayne

48202

Henry Ford Hospital, Detroit

50009

Kaunas Medical University Hospital, Kaunas

51101

Siouxland Regional Cancer Center, Sioux City

53792

University of Wisconsin, Madison

55455

University of Minnesota Cancer Center, Minneapolis

56100

Ospedale S Chiara, University of Pisa, Pisa

59020

Centre Oscar Lambret, Lille

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

69373

Centre Léon Bérard, Lyon

72205

The University of Arkansas for Medical Sciences, Little Rock

75230

Texas Oncology, Dallas

76104

Texas Oncology, Fort Worth

85013

Virginia G. Piper Cancer Center, Arizona Oncology Services, Phoenix

86021

CHU Poitiers, Poitiers

90095

University of California at Los Angeles, Los Angeles

92210

Centre Rene Huguenin, Saint-Cloud

94115

UCSF - Comprehensive Cancer Center, San Francisco

94704

Alta Bates Comprehensive Cancer Center, Berkeley

95816

Radiological Associates of Sacramento, Sacramento

98101

Virginia Mason Cancer Center, Seattle

98801

Wenatchee Valley Clinic, Wenatchee

85724-5081

Arizona Cancer Center, University of Arizona, Tucson

06520

Yale University School of Medicine, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

C1426ANZ

Instituto Medico Especializado Alexander Fleming, Buenos Aires

CP 1417

Instituto de Oncologia A. Roffo, Buenos Aires

CP C1209

Hospital Espanol, Buenos Aires

CP 5000

Instituto Privado de Radioterapia y Oncologia, Córdoba

A-8036

LKH-Universitatsklinikum Graz, Graz

60430-230

Hospital Sao Lucas PUC, Teófilo

14780-400

Fundação Pio XII - Hospital do Câncer de Barretos, Barretos

81520-060

Hospital Erasto Gaertner, Curitiba

90610-000

Velindre Hospital, Porto Alegre

CEP 90020-090

Hospital Santa Rita da Irmandade da Santa Casa, Porto Alegre

CEP 03102-002

Instituto Brasileiro de Controle do Cancer, São Paulo

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Center, Edmonton

L8V 5C2

Juravinski Cancer Centre, Hamilton

K1H 1C4

Ottawa Regional Cancer Centre, Ottawa

M5G 2M9

Princess Margaret Hospital, Toronto

H1T 2M4

Hopital Maisonneuve-Rosemont, Montreal

H2L 4M1

CHUM - Campus Notre Dame, Montreal

H2W 1S6

McGill University, Montreal

G1R 5C3

Hotel-Dieu de Quebec du CHUQ, Québec

J1H 5N4

Centre Hospitalier Universitarie de Service de Radio-Oncologie, Sherbrooke

Unknown

Cilnica Santa Maria, Providencia

06 189

Centre Antioned Lacasagne, Nice

94 805

Institut Gustave Roussy, Villejuif

151 23

Hygeia Diagnostic and Therapeutic Center of Athens, Athens

H-6720

University of Szeged, Szeged

LT-086660

Institute of Oncology, Vilnius University, Vilnius

08907

Instituto Catalan de Oncologia (ICO), Barcelona

CF14 2TL

Velindre Hospital, Whitchurch

BN2 5BE

Royal Sussex County Hospital, Brighton

G11 6NT

Beatson Oncolgy Center, Glasgow

All Listed Sponsors
lead

Spectrum Pharmaceuticals, Inc

INDUSTRY

NCT00083304 - Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer | Biotech Hunter | Biotech Hunter