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

Phase 3

Completed

Conditions: Lung Cancer
Metastatic Cancer
Prostate Cancer
Breast Cancer
Pain

Interventions: Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: Sm-153
Drug: zoledronic acid
Radiation: Sr-89

Registration Number: NCT00365105

Lead Sponsor: Radiation Therapy Oncology Group

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 261

Inclusion Criteria

Histologically or cytologically proven diagnosis of solid tumor malignancy of lung, breast, or prostate prior to registration;
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;
≥ 18 years of age;
Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries;
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.
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.
Women of childbearing potential and male participants must agree to practice an adequate means of birth control throughout their participation in the study.
Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria

Patients with brain metastases and/or spinal cord compression are excluded. Note: Patients with no evidence of disease in the brain after treatment for brain metastases are eligible.
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).
Prior treatment with Strontium-89 or Samarium-153 for bone metastases.
Treatment for more than 6 months with IV bisphosphonates prior to study entry;
Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to registration
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.
Pregnant or lactating patients are excluded, as treatment may be harmful to embryos and/or nursing infants.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid + Radiopharmaceuticals	Sm-153	Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Zoledronic acid	Vitamin D	Zoledronic acid, vitamin D and calcium supplements.
Zoledronic acid + Radiopharmaceuticals	Sr-89	Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Zoledronic acid	Calcium	Zoledronic acid, vitamin D and calcium supplements.
Zoledronic acid + Radiopharmaceuticals	Calcium	Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Zoledronic acid	zoledronic acid	Zoledronic acid, vitamin D and calcium supplements.
Zoledronic acid + Radiopharmaceuticals	zoledronic acid	Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.

Primary Outcome Measures

Name	Time	Method
Time to Development of a Malignant Skeletal-related Events (SRE)	From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.	Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year	From randomization to 1 year	Skeletal-related events are defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.
Overall Survival	From randomization to last follow-up. Maximum follow-up at time of analysis was 101.7 months.	Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year	Baseline and 1 year	The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change score at one year is calculated as one year score - baseline score with a positive change score indicating improvement in QOL.
Change in Brief Pain Inventory (BPI) at One Year	Baseline and 1 year	The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain. The BPI assesses severity (pain at its "worst," "least," "average," and "now"), and interference (how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Patients rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function on a scale of 0 to 10, with 0=no pain/interference and 10=interferes completely/worst pain imaginable.
Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year	Baseline and 1 year	The EQ-5D-3L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Change at one year is calculated as one-year score - baseline score with positive change indicating improved quality of life.

Trial Locations

Locations (147): Providence Cancer Center at Providence Hospital
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Mobile, Alabama, United States
Radiation Oncology Center - Roseville
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Roseville, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
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Pomona, California, United States
General Robert Huyser Cancer Center at David Grant Medical Center
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Travis Air Force Base, California, United States
Bay Medical
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Panama City, Florida, United States
McFarland Clinic, PC
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Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, United States
Great Falls Clinic - Main Facility
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Great Falls, Montana, United States
Sands Cancer Center
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Canandaigua, New York, United States
Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center
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Plattsburgh, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
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Charlotte, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
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Akron, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
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Akron, Ohio, United States
Radiation Oncology Center
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Alliance, Ohio, United States
Cancer Treatment Center
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Wooster, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
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Wright-Patterson Air Force Base, Ohio, United States
UPMC Cancer Center at Beaver Medical Center
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Beaver, Pennsylvania, United States
Northeast Radiation Oncology Center
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Dunmore, Pennsylvania, United States
UPMC - Moon
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Moon, Pennsylvania, United States
UPMC Cancer Center - Natrona Heights
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Natrona Heights, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
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Seneca, Pennsylvania, United States
UPMC Cancer Center - Uniontown
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Uniontown, Pennsylvania, United States
St. Francis Hospital
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Federal Way, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
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Tacoma, Washington, United States
CCOP - Virginia Mason Research Center
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Seattle, Washington, United States
Integrated Community Oncology Network
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Jacksonville Beach, Florida, United States
Mercy Cancer Center at Mercy San Juan Medical Center
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Carmichael, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Northwest Community Hospital
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Arlington Heights, Illinois, United States
CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, United States
CCOP - Columbus
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Columbus, Ohio, United States
Middletown Regional Hospital
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Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
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Kettering, Ohio, United States
Cancer Care Center, Incorporated
🇺🇸
Salem, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
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Troy, Ohio, United States
UPMC Cancer Center at UPMC Presbyterian
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Pittsburgh, Pennsylvania, United States
Mount Nittany Medical Center
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State College, Pennsylvania, United States
Good Samaritan Cancer Center
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Puyallup, Washington, United States
Miami Cancer Center at Mercy Hospital
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Miami, Florida, United States
Baptist Medical Center South
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Jacksonville, Florida, United States
Baptist Cancer Institute - Jacksonville
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Jacksonville, Florida, United States
Integrated Community Oncology Network at Southside Cancer Center
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Jacksonville, Florida, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
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Fort Lauderdale, Florida, United States
CCOP - Mount Sinai Medical Center
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Miami Beach, Florida, United States
Florida Cancer Center - Palatka
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Palatka, Florida, United States
Integrated Community Oncology Network - Orange Park
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Orange Park, Florida, United States
St. Agnes Hospital Cancer Center
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Baltimore, Maryland, United States
University Medical Center at Princeton
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Princeton, New Jersey, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Dearborn, Michigan, United States
Flagler Cancer Center
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Saint Augustine, Florida, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
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Lewiston, Maine, United States
Princeton Radiation Oncology Center
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Jamesburg, New Jersey, United States
Genesys Hurley Cancer Institute
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Flint, Michigan, United States
Tulane Cancer Center Office of Clinical Research
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Alexandria, Louisiana, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
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Fall River, Massachusetts, United States
Cape Cod Hospital
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Hyannis, Massachusetts, United States
Hurley Medical Center
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Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
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Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center
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Kalamazoo, Michigan, United States
Bronson Methodist Hospital
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Kalamazoo, Michigan, United States
Dickinson County Healthcare System
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Iron Mountain, Michigan, United States
Regional Cancer Center at Singing River Hospital
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Pascagoula, Mississippi, United States
St. John Macomb Hospital
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Warren, Michigan, United States
CCOP - Montana Cancer Consortium
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Billings, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
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Kearney, Nebraska, United States
Northern Rockies Radiation Oncology Center
🇺🇸
Billings, Montana, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Marlton, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
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Voorhees, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
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Vineland, New Jersey, United States
CCOP - Greenville
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Greenville, South Carolina, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Murray, Utah, United States
Dixie Regional Medical Center - East Campus
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Saint George, Utah, United States
Riverview UW Cancer Center at Riverview Hospital
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Wisconsin Rapids, Wisconsin, United States
Theda Care Cancer Institute
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Appleton, Wisconsin, United States
Bellin Memorial Hospital
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Green Bay, Wisconsin, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
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Burbank, California, United States
John B. Amos Cancer Center
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Columbus, Georgia, United States
Northeast Georgia Medical Center
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Gainesville, Georgia, United States
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
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Downers Grove, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Harvey, Illinois, United States
Veterans Affairs Medical Center - Hines
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Hines, Illinois, United States
Advocate Christ Medical Center
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Oak Lawn, Illinois, United States
Advocate Lutheran General Cancer Care Center
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Park Ridge, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peoria, Illinois, United States
Cancer Institute at St. John's Hospital
🇺🇸
Springfield, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
Cancer Center at Ball Memorial Hospital
🇺🇸
Muncie, Indiana, United States
Center for Cancer Care at Goshen General Hospital
🇺🇸
Goshen, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸
South Bend, Indiana, United States
St. John's Regional Health Center
🇺🇸
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸
Springfield, Missouri, United States
New York Methodist Hospital
🇺🇸
Brooklyn, New York, United States
Mission Hospitals - Memorial Campus
🇺🇸
Asheville, North Carolina, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸
Canton, Ohio, United States
Wayne Radiation Oncology
🇺🇸
Goldsboro, North Carolina, United States
Barberton Citizens Hospital
🇺🇸
Barberton, Ohio, United States
MedCentral - Mansfield Hospital
🇺🇸
Mansfield, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸
Xenia, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion
🇺🇸
Greensburg, Pennsylvania, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸
Tulsa, Oklahoma, United States
UPMC Cancer Center at Jefferson Regional Medical Center
🇺🇸
Clairton, Pennsylvania, United States
UPMC Cancer Center at the John P. Murtha Pavilion
🇺🇸
Johnstown, Pennsylvania, United States
UPMC - Shadyside
🇺🇸
Pittsburgh, Pennsylvania, United States
Jameson Memorial Hospital - North Campus
🇺🇸
New Castle, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
🇺🇸
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
Washington Hospital Cancer Center
🇺🇸
Washington, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
🇺🇸
York, Pennsylvania, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸
Tacoma, Washington, United States
CCOP - Northwest
🇺🇸
Tacoma, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
🇺🇸
Yakima, Washington, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸
Salt Lake City, Utah, United States
LDS Hospital
🇺🇸
Salt Lake City, Utah, United States
Lawrence Memorial Hospital
🇺🇸
Lawrence, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸
Sheridan, Wyoming, United States
Trinity CancerCare Center
🇺🇸
Minot, North Dakota, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸
Lansing, Michigan, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸
Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸
Tampa, Florida, United States
Saint Joseph Mercy Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
Truman Medical Center - Hospital Hill
🇺🇸
Kansas City, Missouri, United States
CCOP - Kansas City
🇺🇸
Kansas City, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸
Charleston, South Carolina, 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
Samaritan North Cancer Care Center
🇺🇸
Dayton, Ohio, United States
CCOP - Dayton
🇺🇸
Dayton, Ohio, United States
CCOP - Wichita
🇺🇸
Wichita, Kansas, United States
New Mexico Cancer Center
🇺🇸
Albuquerque, New Mexico, 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
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
Billings Clinic - Downtown
🇺🇸
Billings, Montana, United States
Adena Regional Medical Center
🇺🇸
Chillicothe, Ohio, United States
UPMC Cancer Center at UPMC McKeesport
🇺🇸
McKeesport, Pennsylvania, United States