Spots Global Cancer Trial Database for Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
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Trial Identification
Brief Title: Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Official Title: A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
Study ID: NCT00005887
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.
Detailed Description: OBJECTIVES: * 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 patients. * 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 treatment arms. * 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 this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
California Cancer Care, Inc., Greenbrae, California, United States
Scripps Green Hospital & Scripps Clinic, La Jolla, California, United States
Tower Hematology Oncology Medical Group, Los Angeles, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Comprehensive Cancer Care Specialists of Boca Raton, Boca Raton, Florida, United States
Citrus Memorial Hospital, Inverness, Florida, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Ochsner Clinic, New Orleans, Louisiana, United States
Harbor Hospital Center, Baltimore, Maryland, United States
St. Agnes Healthcare, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Lahey Clinic - Burlington, Burlington, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
East Coast Radiation Oncology, Toms River, New Jersey, United States
Millard Fillmore Hospital, Buffalo, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Bismarck Cancer Center, Bismarck, North Dakota, United States
Akron General Medical Center, Akron, Ohio, United States
Akron City Hospital, Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Memphis Regional Brain Tumor Center, Memphis, Tennessee, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group, Memphis, Tennessee, United States
U.S. Oncology Research Inc., Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Center for Radiation Oncology, Danville, Virginia, United States
Massey Cancer Center, Richmond, Virginia, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital Medical Center, Sydney, New South Wales, Australia
Queensland Radium Institute, Herston, Queensland, Australia
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre, Heidelberg West, Victoria, Australia
Institut Jules Bordet, Brussels (Bruxelles), , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels (Bruxelles), , Belgium
UZ De Pintelaan, Gent, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
St. Boniface General Hospital, Winnipeg, Manitoba, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon, , France
CHU de la Timone, Marseille, , France
Hopital de Montbeliard, Montbeliard, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Radiologische Uniklink, Freiburg, , Germany
Universitats-Krankenhaus Eppendorf, Hamburg, , Germany
Uzsoki Hospital, Budapest, , Hungary
University of Debrecen, Debrecen, , Hungary
Petz Aladar County Hospital, Gydr, , Hungary
Borsod-Abauj-Zemplen County Hospital, Miskolc, , Hungary
Szeged University, Szeged, , Hungary
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Istituto Europeo Di Oncologia, Milano, , Italy
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Contact Details
Name: Edward G. Shaw, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
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