Breast Cancer

Bone Metastasis

Pain

chemoradiation

Rabin Medical Center, Beilinson Campus

Chemoradiation for Bone Metastasis

Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis

Patients were asked to score their pain on a scale of 0 (no pain) to 10 (worst possible pain) before treatment and at 1, 2, 4, 8 and 12 weeks after treatment initiation.

Consumption of analgesics was evaluated by the physician using the 5-point WHO score, as follows: level 0, no analgesics required; level 1, non-narcotic analgesics required occasionally; level 2, non-narcotic analgesics required regularly; level 3, narcotic analgesics required occasionally; level 4, narcotic analgesics required regularly

Rabin Medical Center

Sheba Medical Center

Zoledronic acid, vitamin D and calcium supplements.

Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.

Zoledronic Acid

Zoledronic Acid + Radiopharmaceuticals

Total

Sex: Female, Male

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.

Time to Development of a Malignant Skeletal-related Events (SRE)

Skeletal-related events are defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.

Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year

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.

Overall Survival

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 Functional Assessment of Cancer Therapy - General (FACT-G) at One 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 Brief Pain Inventory (BPI) at One 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.

Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year

Overall Study

Wendy Seiferheld

Lung Cancer

Metastatic Cancer

Prostate Cancer

At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.

Calcium

400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.

Vitamin D

4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.

zoledronic acid

Single dose intravenously 1 mCi/kg body weight.

Sm-153

Sr-89

Providence Cancer Center at Providence Hospital

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Mercy Cancer Center at Mercy San Juan Medical Center

USC/Norris Comprehensive Cancer Center and Hospital

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Radiation Oncology Center - Roseville

Radiological Associates of Sacramento Medical Group, Incorporated

General Robert Huyser Cancer Center at David Grant Medical Center

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Integrated Community Oncology Network

Baptist Cancer Institute - Jacksonville

Integrated Community Oncology Network at Southside Cancer Center

Baptist Medical Center South

CCOP - Mount Sinai Medical Center

Miami Cancer Center at Mercy Hospital

Integrated Community Oncology Network - Orange Park

Florida Cancer Center - Palatka

Bay Medical

Flagler Cancer Center

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

John B. Amos Cancer Center

Northeast Georgia Medical Center

Northwest Community Hospital

Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Veterans Affairs Medical Center - Hines

Advocate Christ Medical Center

Advocate Lutheran General Cancer Care Center

Oncology Hematology Associates of Central Illinois, PC - Peoria

Cancer Institute at St. John's Hospital

CCOP - Carle Cancer Center

Center for Cancer Care at Goshen General Hospital

Cancer Center at Ball Memorial Hospital

CCOP - Northern Indiana CR Consortium

McFarland Clinic, PC

CCOP - Iowa Oncology Research Association

John Stoddard Cancer Center at Iowa Methodist Medical Center

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Medical Oncology and Hematology Associates at Mercy Cancer Center

Mercy Cancer Center at Mercy Medical Center - Des Moines

Siouxland Hematology-Oncology Associates, LLP

Lawrence Memorial Hospital

CCOP - Wichita

Central Baptist Hospital

Tulane Cancer Center Office of Clinical Research

Central Maine Comprehensive Cancer Center at Central Maine Medical Center

St. Agnes Hospital Cancer Center

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Cape Cod Hospital

Saint Joseph Mercy Cancer Center

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Josephine Ford Cancer Center at Henry Ford Hospital

Genesys Hurley Cancer Institute

Hurley Medical Center

Van Elslander Cancer Center at St. John Hospital and Medical Center

Dickinson County Healthcare System

West Michigan Cancer Center

Bronson Methodist Hospital

Sparrow Regional Cancer Center

St. John Macomb Hospital

CentraCare Clinic - River Campus

Regional Cancer Center at Singing River Hospital

Truman Medical Center - Hospital Hill

CCOP - Kansas City

St. John's Regional Health Center

Hulston Cancer Center at Cox Medical Center South

CCOP - Montana Cancer Consortium

Northern Rockies Radiation Oncology Center

Billings Clinic - Downtown

Great Falls Clinic - Main Facility

Good Samaritan Cancer Center at Good Samaritan Hospital

Princeton Radiation Oncology Center

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

University Medical Center at Princeton

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

Cancer Institute of New Jersey at Cooper - Voorhees

New Mexico Cancer Center

New York Methodist Hospital

Sands Cancer Center

Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center

Highland Hospital of Rochester

Lipson Cancer and Blood Center at Rochester General Hospital

University Radiation Oncology at Parkridge Hospital

James P. Wilmot Cancer Center at University of Rochester Medical Center

Mission Hospitals - Memorial Campus

Presbyterian Cancer Center at Presbyterian Hospital

Wayne Radiation Oncology

Trinity CancerCare Center

McDowell Cancer Center at Akron General Medical Center

Summa Center for Cancer Care at Akron City Hospital

Radiation Oncology Center

Barberton Citizens Hospital

Mercy Cancer Center at Mercy Medical Center

Adena Regional Medical Center

CCOP - Columbus

Grandview Hospital

Good Samaritan Hospital

David L. Rike Cancer Center at Miami Valley Hospital

Samaritan North Cancer Care Center

CCOP - Dayton

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

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

NRG Oncology

filgrastim

CAF regimen

carboplatin

cisplatin

cyclophosphamide

doxorubicin hydrochloride

fluorouracil

ifosfamide

melphalan

paclitaxel

thiotepa

peripheral blood stem cell transplantation

samarium Sm 153 lexidronam pentasodium

Louisiana State University School of Medicine

Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer

Phase I/II Study of Samarium 153 as Part of a Double (Sequential) Autologous Bone Marrow Transplant (ABMT) for Patients With Stage IV Breast Cancer

Louisiana State University Health Sciences Center Shreveport

samarium

breast neoplasms

samarium/breast neoplasms

Chemoradiation for Bone Metastasis

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

Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer

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