Spots Global Cancer Trial Database for Intravesical BCG vs GEMDOCE in NMIBC
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Trial Identification
Brief Title: Intravesical BCG vs GEMDOCE in NMIBC
Official Title: A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
Study ID: NCT05538663
Conditions
Study Description
Brief Summary: The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
Detailed Description: The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States
CARTI Cancer Center, Little Rock, Arkansas, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Boulder Community Foothills Hospital, Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial, Centennial, Colorado, United States
The Women's Imaging Center, Denver, Colorado, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
George Washington University Medical Center, Washington, District of Columbia, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital, Emmett, Idaho, United States
Idaho Urologic Institute-Meridian, Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
Kootenai Cancer Clinic, Sandpoint, Idaho, United States
Saint Anthony's Health, Alton, Illinois, United States
Saint Mary's Hospital, Centralia, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
North Shore Medical Center, Skokie, Illinois, United States
Reid Health, Richmond, Indiana, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic - Ames, Ames, Iowa, United States
McFarland Clinic - Boone, Boone, Iowa, United States
McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
McFarland Clinic - Jefferson, Jefferson, Iowa, United States
McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States
Central Care Cancer Center - Garden City, Garden City, Kansas, United States
Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Mercy Health - Paducah Medical Oncology and Hematology, Paducah, Kentucky, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie, Louisiana, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
Maine Medical Partners Urology, South Portland, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing, Lansing, Michigan, United States
Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States
Cox Cancer Center Branson, Branson, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Mercy Hospital Joplin, Joplin, Missouri, United States
Lake Regional Hospital, Osage Beach, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Mercy Hospital Washington, Washington, Missouri, United States
Community Hospital of Anaconda, Anaconda, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School, Newark, New Jersey, United States
Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Albany Medical Center, Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Indu and Raj Soin Medical Center, Beavercreek, Ohio, United States
Saint Elizabeth Boardman Hospital, Boardman, Ohio, United States
Dayton Physicians LLC-Miami Valley South, Centerville, Ohio, United States
Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Dayton Physician LLC-Miami Valley Hospital North, Dayton, Ohio, United States
Armes Family Cancer Center, Findlay, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Orion Cancer Care, Findlay, Ohio, United States
Dayton Physicians LLC-Atrium, Franklin, Ohio, United States
Dayton Physicians LLC-Wayne, Greenville, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Greater Dayton Cancer Center, Kettering, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Dayton Physicians LLC - Troy, Troy, Ohio, United States
Saint Joseph Warren Hospital, Warren, Ohio, United States
Saint Elizabeth Youngstown Hospital, Youngstown, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States
Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Portland VA Medical Center, Portland, Oregon, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center-Rockledge, Rockledge, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Ralph H Johnson VA Medical Center, Charleston, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
MUSC Health Florence Medical Center, Florence, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Lexington Medical Center, West Columbia, South Carolina, United States
MD Anderson in The Woodlands, Conroe, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Ben Taub General Hospital, Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Michael E DeBakey VA Medical Center, Houston, Texas, United States
MD Anderson West Houston, Houston, Texas, United States
MD Anderson League City, League City, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
Jefferson Healthcare, Port Townsend, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
FHCC South Lake Union, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States
Billings Clinic-Cody, Cody, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
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