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A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastases

Thank you

Trial Information

A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer


The screening process will include documentation of the cancer, which which will require a
brain scan and may include a liver scan. Other screening measurements will include a
Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the
blood, using a non-invasive device most often placed on the finger, lung function tests that
will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or
10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be
done on the blood of women of childbearing potential.

All study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT)
(30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized
(assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed
for treatment unless one is already in place. Patients who receive RSR13 will also need to
continue to receive oxygen in the clinic until the amount of oxygen in their blood is near
normal. This level has returned to near normal in most patients within 1 to 2 hours.

During treatment and follow-up visits, physical and neurological exam, KPS assessment,
weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required.
Patients will need to return for follow-up visits 1 month after completion of treatment, 2
months later, and every 3 months thereafter until their doctor tells them otherwise.


Inclusion Criteria:



- Adult women with brain metastases from breast cancer

- Minimum KPS of 70

Exclusion Criteria:

- Previous treatment for brain metastases, including brain surgery and any form of
radiation to the brain

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

Measured from randomization until death due to any cause.

Safety Issue:

No

Principal Investigator

John Suh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

RT-016

NCT ID:

NCT00083304

Start Date:

February 2004

Completion Date:

June 2007

Related Keywords:

  • Breast Cancer
  • Metastases
  • Breast
  • Brain
  • RSR13
  • efaproxiral
  • Whole Brain Radiation Therapy
  • Brain metastases
  • Metastatic breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Henry Ford HospitalDetroit, Michigan  48202
Franklin Square Hospital CenterBaltimore, Maryland  21237
SUNY Downstate Medical CenterBrooklyn, New York  11203
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Wenatchee Valley ClinicWenatchee, Washington  98801
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Ohio State UniversityColumbus, Ohio  43210
Texas OncologyDallas, Texas  
Eastchester Center for Cancer CareBronx, New York  10469
Yale University School Of MedicineNew Haven, Connecticut  06520
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Boca Raton Community HospitalBoca Raton, Florida  33486
University of WisconsinMadison,, Wisconsin  53792-5666
Virginia G. Piper Cancer Center, Arizona Oncology ServicesPhoenix, Arizona  85013
Arizona Cancer Center, University of ArizonaTucson, Arizona  85724-5081
The University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of California at Los AngelesLos Angeles, California  90095
Radiological Associates of SacramentoSacramento, California  95816
UCSF - Comprehensive Cancer CenterSan Francisco, California  94115
University of Miami MedicalMiami, Florida  33136
University of South Florida - H. Lee Moffitt Cancer CenterTampa, Florida  33612
Emory University Winship Cancer InstituteAtlanta, Georgia  30322
Parkview Research CenterFt. Wayne, Indiana  46805
Indiana University School of MedicineIndianapolis, Indiana  46204
Maryland Hematology OncologyBaltimore, Maryland  21236
Dent Neurologic InstituteAmherst, New York  14226
University of North Carolina Breast CenterChapel Hill, North Carolina  27599
University of Cincinnati Division of Hematology-OncologyCincinnati, Ohio  45267
Cleveland Clinic HospitalCleveland, Ohio  44195
Virginia Mason Cancer CenterSeattle, Washington  98101