Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
NCT ID: NCT00005887
Last Updated: 2021-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2000-02-29
2003-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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efaproxiral
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:
* Small cell lung cancer, germ cell tumors, and lymphomas
* No leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* WBC at least 2,000/mm3
* Platelet count at least 75,000/mm3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* ALT and AST no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Pulmonary:
* Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism
* Resting and exercise oxygen saturation at least 90% on room air
Other:
* No other concurrent active malignancy from a second histologic site
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy or immunotherapy for brain metastases
* At least 28 days since prior investigational biologic therapy
Chemotherapy:
* No prior chemotherapy for brain metastases
* No chemotherapy for brain metastases for at least one month following radiation therapy
* At least 7 days since prior chemotherapy for primary tumor or extracranial metastases
* No planned chemotherapy during radiation therapy
Endocrine therapy:
* No prior hormonal therapy for brain metastases
* Prior or concurrent corticosteroid therapy allowed
Radiotherapy:
* No prior whole brain radiotherapy for brain metastases
* No prior stereotactic radiosurgery for brain metastases
Surgery:
* Prior surgery allowed for brain metastases if at least one measurable lesion remains
Other:
* At least 28 days since prior investigational drug or device
* No prior RSR13
18 Years
120 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Edward G. Shaw, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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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
Ghent, , 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. John's, 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
Québec, 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
Montbéliard, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Radiologische Uniklink
Freiburg im Breisgau, , 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
Milan, , Italy
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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Suh JH, Stea B, Nabid A, Kresl JJ, Fortin A, Mercier JP, Senzer N, Chang EL, Boyd AP, Cagnoni PJ, Shaw E. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. J Clin Oncol. 2006 Jan 1;24(1):106-14. doi: 10.1200/JCO.2004.00.1768. Epub 2005 Nov 28.
Nabid A, Kresl J, Stea B, et al.: Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: results of a subgroup analysis. [Abstract] J Clin Oncol 22 (Suppl 14): A-7115, 645s, 2004.
Shaw E, Stea B, Pinter T, et al.: Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009). [Abstract] J Clin Oncol 22 (Suppl 14): A-1561, 122s, 2004.
Stea B, Suh J, Shaw E, et al.: Efaproxiral (EFAPROXYN) as an adjunct to whole brain radiation therapy for the treatment of brain metastases originating from breast cancer: updated survival results of the randomized REACH (RT-009) study. [Abstract] Breast Cancer Res Treat 88 (1): A-4064, 2004.
Suh J, Stea BD, Nabid A, et al.: Prognostic factors for survival in patients with brain metastases enrolled on a worldwide phase 3 randomized trial of 538 patients (study RSR13 RT-009). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-60, S165, 2004.
Suh J, Stea B, Nabid A, et al.: Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral) in patients with brain metastases: results of the randomized REACH (RT-009) study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1534, 115s, 2004.
Other Identifiers
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ALLOS-RSR13RT-009
Identifier Type: -
Identifier Source: secondary_id
CDR0000067957
Identifier Type: -
Identifier Source: org_study_id
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