Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases

NCT00005887 | Completed Phase 3

• 2 other identifiers: CDR0000067957ALLOS-RSR13RT-009
• Study Type: interventional
• Target: N/A
• Locations: 9 countries
• Sites: 73

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.

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Interventions

efaproxiral DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (73)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85001-2071, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

Scripps Green Hospital & Scripps Clinic

La Jolla, California, 92037, United States

Location

Tower Hematology Oncology Medical Group

Los Angeles, California, 90048, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Comprehensive Cancer Care Specialists of Boca Raton

Boca Raton, Florida, 33428, United States

Location

Citrus Memorial Hospital

Inverness, Florida, 34452, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

St. Agnes Healthcare

Baltimore, Maryland, 21229, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Lahey Clinic - Burlington

Burlington, Massachusetts, 01805, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

East Coast Radiation Oncology

Toms River, New Jersey, 08755, United States

Location

Millard Fillmore Hospital

Buffalo, New York, 14209, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501-4445, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Akron City Hospital

Akron, Ohio, 44309, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Memphis Regional Brain Tumor Center

Memphis, Tennessee, 38104, United States

Location

Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

Memphis, Tennessee, 38119, United States

Location

U.S. Oncology Research Inc.

Dallas, Texas, 75246, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Center for Radiation Oncology

Danville, Virginia, 24541, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Royal Prince Alfred Hospital Medical Center

Sydney, New South Wales, 2042, Australia

Location

Queensland Radium Institute

Herston, Queensland, 4029, Australia

Location

Peter MacCallum Cancer Institute

East Melbourne, Victoria, 8006, Australia

Location

Austin and Repatriation Medical Centre

Heidelberg West, Victoria, 3081, Australia

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels (Bruxelles), 1090, Belgium

Location

UZ De Pintelaan

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Hopital de Montbeliard

Montbéliard, 25200, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Radiologische Uniklink

Freiburg im Breisgau, D-79106, Germany

Location

Universitats-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Uzsoki Hospital

Budapest, 1145, Hungary

Location

University of Debrecen

Debrecen, 1389/990TE-, Hungary

Location

Petz Aladar County Hospital

Gydr, h-9024, Hungary

Location

Borsod-Abauj-Zemplen County Hospital

Miskolc, 3501, Hungary

Location

Szeged University

Szeged, H-6720, Hungary

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 16314619 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

efaproxiral; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: August 29, 2003
• Study Start: February 1, 2000
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

BE (4); IT (2); AU (4); HU (5); US (35); DE (2); GB (2); FR (4); CA (15)