A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
- Compare the median survival time in patients with brain metastases after receiving
treatment with whole brain radiotherapy with or without RSR13.
- Compare the response rate to these treatment regimens in these patients.
- Compare the time to progression after receiving these treatment regimens in these
- Compare quality of life in these patients receiving these treatment regimens.
- Compare cause of death (neurologic vs nonneurologic death) in these patients after
receiving these treatment regimens.
- Determine the safety of RSR13 in these patients.
- Assess the pharmacokinetics of RSR13 in these patients.
OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are
stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients
are further stratified within the RPA class II stratum according to site of primary cancer
(non-small cell lung cancer vs breast vs other). Patients are randomized to one of two
- Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in
conjunction with supplemental oxygen breathing.
- Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy
and supplemental oxygen breathing as in arm I.
Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months,
and then every 3 months until disease progression.
Patients are followed at 1 month, 3 months, every 3 months until disease progression, and
then for survival.
PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Edward G. Shaw, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Akron City Hospital||Akron, Ohio 44304|
|Arizona Cancer Center||Tucson, Arizona 85724|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Colorado Cancer Center||Denver, Colorado 80262|
|University of Massachusetts Memorial Medical Center||Worcester, Massachusetts 01655|
|Cooper Hospital/University Medical Center||Camden, New Jersey 08103|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|St. Joseph's Hospital and Medical Center||Phoenix, Arizona 85001-2071|
|Harbor Hospital Center||Baltimore, Maryland 21225|
|Akron General Medical Center||Akron, Ohio 44302|
|Massey Cancer Center||Richmond, Virginia 23298-0037|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)||Milwaukee, Wisconsin 53295|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Lahey Clinic - Burlington||Burlington, Massachusetts 01805|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|Ochsner Clinic||New Orleans, Louisiana 70121|
|California Cancer Care, Inc.||Greenbrae, California 94904-2007|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Alta Bates Comprehensive Cancer Center||Berkeley, California 94704|
|Bismarck Cancer Center||Bismarck, North Dakota 58501|
|U.S. Oncology Research Inc.||Houston, Texas 77060|
|Comprehensive Cancer Care Specialists of Boca Raton||Boca Raton, Florida 33428|
|Tower Hematology Oncology Medical Group||Los Angeles, California 90048|
|Scripps Green Hospital & Scripps Clinic||La Jolla, California 92037|
|Citrus Memorial Hospital||Inverness, Florida 34452|
|St. Agnes Healthcare||Baltimore, Maryland 21229|
|East Coast Radiation Oncology||Toms River, New Jersey 08755|
|Millard Fillmore Hospital||Buffalo, New York 14209|
|Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group||Memphis, Tennessee 38119|
|Memphis Regional Brain Tumor Center||Memphis, Tennessee 38104|
|Center for Radiation Oncology||Danville, Virginia 24541|