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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Prostate, and Breast

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

Unique Dataset IDnci-data-421ClinicalTrial.gov IDNCT00365105
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients261RandomizationYesPubMed (PMID)30094545.0
Study PhaseN/ABlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, RadiationDataset TypeN/A

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See Data Dictionary.

Study 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.

Outcome Measures

Primary: Time to Development of a Malignant Skeletal-related Events (SRE) [ Time Frame: 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.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

Data 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.

Available Downloads: NCT00365105-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00365105-D1-Data-Dictionary_5.pdf

DATA: NCT00365105-D1-Dataset_2.csv

OTHER: README.pdf

Available Downloads: NCT00365105-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00365105-D2-Data-Dictionary_2.pdf

DATA: NCT00365105-D2-Dataset_2.csv

OTHER: README.pdf