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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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Central Nervous System

Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma

Unique Dataset IDnci-data-21ClinicalTrial.gov IDNCT03015701
DownloadableNo
SponsorSouthwest Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients193RandomizationYesPubMed (PMID)26527781.0
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeDrug, PlaceboDataset TypeOther

NCI Description

The dataset NCT03015701-D1-Dataset.csv will allow users to reproduce efficacy analyses included in the aforementioned publication, which included primary and secondary efficacy results evaluating the mifepristone over placebo for the treatment of patients with unresectable meningioma in the SWOG phase III trial, S9005.

Clinical Trial Title

Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma

Trial Summary and Conditions

To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.

Data Summary

See data dictionary for more details.

Study Objectives

To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma and to address issues of safety in this patient population.

Outcome Measures

Primary: Time to Treatment Failure [ Time Frame: 6 years ] Secondary: Incidence of Treatment-Emergent Adverse Events [ Time Frame: two years after beginning treatment ] Safety [ Time Frame: two years after beginning treatment ]

ClinicalTrial.gov

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

Available Downloads:

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