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Type(s) of Cancer
Breast,Lung,Prostate
Study Phase
Phase 3
Study Completion Date
January 2012
NCT00365105Uploaded 07-24-2020
Access via NCI by Request
PDS UID: nci-data-421
Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
Provider Information
Provider Data DescriptionData submissions NCT00365105-D1 and NCT00365105-D2 contain patient-reported acute toxicity and health-related quality of life (QOL) data from trial NCT00365105 to reproduce results PubMed ID=30094545.
SponsorRadiation Therapy Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsBreast Cancer
Lung Cancer
Metastatic Cancer
Pain
Prostate Cancer
Intervention TypeDietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid
Drug: Sm-153
Radiation: Sr-89
Drug(s)Drug: zoledronic acid
Drug: Sm-153
Total Enrolled261
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionZoledronic acid - Active Comparator
Zoledronic acid + Radiopharmaceuticals - Experimental
Secondary IDCDR0000491233
PubMed (PMID)30094545
Collaborator(s)National Cancer Institute (NCI)
NRG Oncology
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Files: NCT00365105-D1
Data DictionaryNCT00365105-D1-Data-Dictionary_5.pdf
DATANCT00365105-D1-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00365105-D2
Data DictionaryNCT00365105-D2-Data-Dictionary_2.pdf
DATANCT00365105-D2-Dataset_2.csv
OTHERREADME.pdf
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