Spots Global Cancer Trial Database for Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer
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Trial Identification
Brief Title: Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer
Official Title: Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
Study ID: NCT00365105
Study Description
Brief Summary: RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
Detailed Description: OBJECTIVES: Primary * Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or delaying the time to development of malignant skeletal-related events (SREs) (defined as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone) in patients with bone metastases secondary to prostate, lung, or breast cancer. Secondary * Compare the rate of SREs at 1 year in patients treated with these regimens. * Compare overall survival of patients treated with these regimens. * Compare quality of life of patients treated with these regimens. * Compare the effect of these regimens on pain control in these patients. * Evaluate resource utilization and cost effectiveness of these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to primary disease site (prostate vs breast vs lung) and number of bone metastases (≤ 2 vs \> 2). Patients are randomized to 1 of 2 treatment arms. Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from start of protocol treatment. After completion of study treatment, patients are followed every 6 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Providence Cancer Center at Providence Hospital, Mobile, Alabama, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center, Burbank, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center, Pomona, California, United States
Radiation Oncology Center - Roseville, Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base, California, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida, United States
Integrated Community Oncology Network, Jacksonville Beach, Florida, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center, Jacksonville, Florida, United States
Baptist Medical Center South, Jacksonville, Florida, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
Miami Cancer Center at Mercy Hospital, Miami, Florida, United States
Integrated Community Oncology Network - Orange Park, Orange Park, Florida, United States
Florida Cancer Center - Palatka, Palatka, Florida, United States
Bay Medical, Panama City, Florida, United States
Flagler Cancer Center, Saint Augustine, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Northwest Community Hospital, Arlington Heights, Illinois, United States
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital, Downers Grove, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
Veterans Affairs Medical Center - Hines, Hines, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Center for Cancer Care at Goshen General Hospital, Goshen, Indiana, United States
Cancer Center at Ball Memorial Hospital, Muncie, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center, Lewiston, Maine, United States
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States
Cape Cod Hospital, Hyannis, Massachusetts, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
Billings Clinic - Downtown, Billings, Montana, United States
Great Falls Clinic - Main Facility, Great Falls, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney, Nebraska, United States
Princeton Radiation Oncology Center, Jamesburg, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
University Medical Center at Princeton, Princeton, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
New Mexico Cancer Center, Albuquerque, New Mexico, United States
New York Methodist Hospital, Brooklyn, New York, United States
Sands Cancer Center, Canandaigua, New York, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center, Plattsburgh, New York, United States
Highland Hospital of Rochester, Rochester, New York, United States
Lipson Cancer and Blood Center at Rochester General Hospital, Rochester, New York, United States
University Radiation Oncology at Parkridge Hospital, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Trinity CancerCare Center, Minot, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Radiation Oncology Center, Alliance, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Mercy Cancer Center at Mercy Medical Center, Canton, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
MedCentral - Mansfield Hospital, Mansfield, Ohio, United States
Cancer Care Center, Incorporated, Salem, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Air Force Base, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
UPMC Cancer Center at Beaver Medical Center, Beaver, Pennsylvania, United States
UPMC Cancer Center at Jefferson Regional Medical Center, Clairton, Pennsylvania, United States
Northeast Radiation Oncology Center, Dunmore, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
UPMC Cancer Center at the John P. Murtha Pavilion, Johnstown, Pennsylvania, United States
UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States
UPMC - Moon, Moon, Pennsylvania, United States
UPMC Cancer Center - Natrona Heights, Natrona Heights, Pennsylvania, United States
Jameson Memorial Hospital - North Campus, New Castle, Pennsylvania, United States
UPMC - Shadyside, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Presbyterian, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC St. Margaret, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Passavant, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center - Upper St. Clair, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
UPMC Cancer Center - Uniontown, Uniontown, Pennsylvania, United States
Washington Hospital Cancer Center, Washington, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center, York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
Dixie Regional Medical Center - East Campus, Saint George, Utah, United States
Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
St. Francis Hospital, Federal Way, Washington, United States
Good Samaritan Cancer Center, Puyallup, Washington, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center, Tacoma, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Theda Care Cancer Institute, Appleton, Wisconsin, United States
Bellin Memorial Hospital, Green Bay, Wisconsin, United States
Riverview UW Cancer Center at Riverview Hospital, Wisconsin Rapids, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Michael J. Seider, MD, PhD, FACR
Affiliation: Summa Center for Cancer Care at Akron City Hospital
Role: STUDY_CHAIR
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