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
NCT ID: NCT00365105
Last Updated: 2024-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2006-07-11
2017-02-27
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Zoledronic acid
Zoledronic acid, vitamin D and calcium supplements.
Calcium
At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
Vitamin D
400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Zoledronic acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Calcium
At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Sm-153
Single dose intravenously 1 mCi/kg body weight.
Sr-89
Single dose intravenously 4 mCi.
Interventions
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Calcium
At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
Vitamin D
400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
zoledronic acid
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Sm-153
Single dose intravenously 1 mCi/kg body weight.
Sr-89
Single dose intravenously 4 mCi.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Appropriate diagnosis for protocol entry, based upon the following minimum diagnostic workup:
2.1 History/physical examination within 8 weeks prior to registration; 2.2 Bone scan within 4 weeks prior to registration; bone metastases must be visible on the scan. Other scanning modalities, such as magnetic resonance imaging (MRI), positron emission tomography (PET) 2.3 Dental evaluation according to the dental exam checklist (carried out by the investigator, the investigator's designee, or by a qualified dental professional \[dental hygienist or dentist\]), including history of dental surgery (e.g., extraction or implant) within 8 weeks prior to registration and recorded on the dental exam checklist; Note: If the patient has received prior oral bisphosphonate therapy and has had a prior dental evaluation within 8 weeks of registration, the evaluation should not be repeated.
2.4 Complete blood count (CBC)/differential within 2 weeks prior to registration, with adequate bone marrow function defined as follows:
* White blood cell count (WBC) ≥ 2400 cells/mm\^3;
* Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
* Platelets ≥ 60,000 cells/mm3;
* Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve the required hemoglobin is permitted).
2.5 Serum creatinine \< 3 mg/dL (265 μmol/L) within 2 weeks prior to registration; 2.6 Total bilirubin \< 2.5 mg/dL (43 μmol/L) within 2 weeks prior to registration; 2.7 Pregnancy test (urine dipstick or serum) for women of childbearing potential within 2 weeks prior to registration;
3. ≥ 18 years of age;
4. Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries;
5. Patients receiving systemic chemotherapy or hormonal therapy are eligible for this study. See Sections 6.0 and 7.0 for further details. Note: All patients must complete external beam radiation therapy ≥ 14 days prior to registration. If patients have undergone CyberKnife treatment, treatment must be completed ≥ 14 days prior to registration.
6. Patients may have received prior oral bisphosphonate therapy, such as Fosamax® or similar medications. Duration of bisphosphonate treatment prior to study entry must be documented, and all bisphosphonates other than the study drug must be discontinued prior to registration.
7. Women of childbearing potential and male participants must agree to practice an adequate means of birth control throughout their participation in the study.
8. Patient must sign study specific informed consent prior to study entry.
Exclusion Criteria
2. Patients with painful bone metastases are not permitted until these bone metastases are successfully treated (for example by external beam irradiation) prior to registration, and the patient has stable pain for at least 2 weeks after that treatment (Stable pain is defined for this study as a patient response of 1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI).
3. Prior treatment with Strontium-89 or Samarium-153 for bone metastases.
4. Treatment for more than 6 months with IV bisphosphonates prior to study entry;
5. Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to registration
6. Severe, active co-morbidity, defined as follows:
6.1 Evidence in the six months prior to study entry of uncontrolled congestive heart failure, hypertension refractory to treatment, or symptomatic coronary artery disease; 6.2 Current, active dental problems within 4 weeks of registration, including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; current or prior diagnosis of osteonecrosis of the jaw (ONJ); exposed bone in the mouth; or slow healing after dental procedures; 6.3 Dental surgery (e.g., extractions, implants) within 6 weeks of study entry and while receiving study treatment; for patients who require dental surgery, there are no data to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw (ONJ) \[see Section 7.2.4\].
6.4 Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
7. Pregnant or lactating patients are excluded, as treatment may be harmful to embryos and/or nursing infants.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Michael J. Seider, MD, PhD, FACR
Role: STUDY_CHAIR
Summa Center for Cancer Care at Akron City Hospital
Locations
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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
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, 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
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
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
Integrated Community Oncology Network
Jacksonville Beach, Florida, United States
Miami Cancer Center at Mercy Hospital
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, 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 Township, 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 Township, 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
Countries
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References
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Seider MJ, Pugh SL, Langer C, Wyatt G, Demas W, Rashtian A, Clausen CL, Derdel JD, Cleary SF, Peters CA, Ramalingam A, Clarkson JE, Tomblyn M, Rabinovitch RA, Kachnic LA, Berk LB; NRG Oncology. Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: report of the NRG Oncology RTOG 0517 trial. Ann Nucl Med. 2018 Oct;32(8):553-560. doi: 10.1007/s12149-018-1278-4. Epub 2018 Aug 9.
Study Documents
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Document Type: Individual Participant Data Set
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View DocumentOther Identifiers
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CDR0000491233
Identifier Type: -
Identifier Source: secondary_id
NCI-2009-00727
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG 0517
Identifier Type: -
Identifier Source: org_study_id
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