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| Sponsor: | Allos Therapeutics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005887 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer |
Drug: efaproxiral Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| 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 Start Date: | February 2000 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| St. Joseph's Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85001-2071 | |
| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Scripps Green Hospital & Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Tower Hematology Oncology Medical Group | |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Florida | |
| Citrus Memorial Hospital | |
| Inverness, Florida, United States, 34452 | |
| Comprehensive Cancer Care Specialists of Boca Raton | |
| Boca Raton, Florida, United States, 33428 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| United States, Louisiana | |
| Ochsner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Harbor Hospital Center | |
| Baltimore, Maryland, United States, 21225 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| St. Agnes Healthcare | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Massachusetts | |
| Lahey Clinic - Burlington | |
| Burlington, Massachusetts, United States, 01805 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New Jersey | |
| Cooper Hospital/University Medical Center | |
| Camden, New Jersey, United States, 08103 | |
| East Coast Radiation Oncology | |
| Toms River, New Jersey, United States, 08755 | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740-6395 | |
| United States, New York | |
| Millard Fillmore Hospital | |
| Buffalo, New York, United States, 14209 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501-4445 | |
| United States, Ohio | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44309 | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44302 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| United States, Tennessee | |
| Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group | |
| Memphis, Tennessee, United States, 38119 | |
| Memphis Regional Brain Tumor Center | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| U.S. Oncology Research Inc. | |
| Dallas, Texas, United States, 75246 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Virginia | |
| Center for Radiation Oncology | |
| Danville, Virginia, United States, 24541 | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| United States, Wisconsin | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Australia, New South Wales | |
| Royal Prince Alfred Hospital Medical Center | |
| Sydney, New South Wales, Australia, 2042 | |
| Australia, Queensland | |
| Queensland Radium Institute | |
| Herston, Queensland, Australia, 4029 | |
| Australia, Victoria | |
| Austin and Repatriation Medical Centre | |
| Heidelberg West, Victoria, Australia, 3081 | |
| Peter MacCallum Cancer Institute | |
| East Melbourne, Victoria, Australia, 8006 | |
| Belgium | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels (Bruxelles), Belgium, 1090 | |
| Institut Jules Bordet | |
| Brussels (Bruxelles), Belgium, 1000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| UZ De Pintelaan | |
| Gent, Belgium, B-9000 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| British Columbia Cancer Agency - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Canada, Manitoba | |
| St. Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L-4M1 | |
| Centre Hospitalier Universitaire de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| CHUS-Hopital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| France | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69310 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Hopital de Montbeliard | |
| Montbeliard, France, 25200 | |
| Germany | |
| Radiologische Uniklink | |
| Freiburg, Germany, D-79106 | |
| Universitats-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Hungary | |
| Borsod-Abauj-Zemplen County Hospital | |
| Miskolc, Hungary, 3501 | |
| Petz Aladar County Hospital | |
| Gydr, Hungary, h-9024 | |
| Szeged University | |
| Szeged, Hungary, H-6720 | |
| University of Debrecen | |
| Debrecen, Hungary, 1389/990TE- | |
| Uzsoki Hospital | |
| Budapest, Hungary, 1145 | |
| Italy | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| Istituto Europeo Di Oncologia | |
| Milano, Italy, 20141 | |
| United Kingdom, England | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| United Kingdom, Scotland | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Study Chair: | Edward G. Shaw, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000067957, ALLOS-RSR13RT-009 |
| Study First Received: | June 2, 2000 |
| Last Updated: | August 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005887 History of Changes |
| Health Authority: | United States: Federal Government |
|
tumors metastatic to brain |
|
Neoplasms Neoplastic Processes Antisickling Agents Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses |
Physiological Effects of Drugs Hematologic Agents Neoplasm Metastasis Pharmacologic Actions Efaproxiral |