Spots Global Cancer Trial Database for Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
Official Title: Steam (Sequencing Triplet With Avastin and Maintenance): FOLFOXIRI/Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
Study ID: NCT01765582
Conditions
Study Description
Brief Summary: This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5 milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs. After disease progression, participants will receive treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of South Alabama; Mitchell Cancer Institute, Mobile, Alabama, United States
Long Beach Memorial Medical Center; Oncology, Long Beach, California, United States
LAC-USC Medical Center, Los Angeles, California, United States
USC Norris Cancer Center, Los Angeles, California, United States
Pacific Cancer Care - Monterey, Monterey, California, United States
Sacramento Center for Hematolo, Sacramento, California, United States
Pacific Cancer Care, Salinas, California, United States
Kaiser Permanente - Franklin, Denver, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Sibley Memorial Hospital, Washington, D.C., District of Columbia, United States
Florida Cancer Specialists - Fort Myers (Colonial Center Dr), Fort Myers, Florida, United States
Florida Cancer Specialist, North Region, Saint Petersburg, Florida, United States
University Cancer & Blood Center, LLC, Athens, Georgia, United States
Emory University Clinic, Atlanta, Georgia, United States
Central Georgia Cancer Care PC, Macon, Georgia, United States
Summit Cancer Care PC, Savannah, Georgia, United States
Ingalls Memorial Hosp, Harvey, Illinois, United States
Edward Cancer Center Naperville, Naperville, Illinois, United States
Edward Cancer Center Plainfield, Plainfield, Illinois, United States
University of Kentucky Medical Center, Lexington, Kentucky, United States
Johns Hopkins Univ; Bunting Blaustein Cancer Center, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
St. Joseph Mercy Hospital; Cancer Care Center., Ann Arbor, Michigan, United States
Karmanos Cancer Institute.., Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology, Lincoln, Nebraska, United States
Nebraska Methodist Hospital; Cancer Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Med Center, Lebanon, New Hampshire, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr, Oklahoma City, Oklahoma, United States
Milton S. Hershey Medical Center; Penn State Cancer Inst., Hershey, Pennsylvania, United States
Chattanooga Oncology and Hematology Associates, PC, Chattanooga, Tennessee, United States
West Clinic, Germantown, Tennessee, United States
Sarah Cannon Cancer Center and Research Institute, Nashville, Tennessee, United States
UT Southwestern MC at Dallas, Dallas, Texas, United States
Ctr for Cancer and Blood Disorders, Fort Worth, Texas, United States
Scott and White Hospital; Cancer Center, Temple, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Seattle Cancer Care Alliance - Evergreen Health, Kirkland, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical Oncology Associates, Spokane, Washington, United States
Vince Lombardi Cancer Center, Green Bay, Wisconsin, United States
Medical College of Wisconsin; Dept Froedtert Clin Can Ctr, Milwaukee, Wisconsin, United States
Aurora Research Institute, Wauwatosa, Wisconsin, United States
Cheyenne Oncology & Hematology Associates, Cheyenne, Wyoming, United States
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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