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Type(s) of Cancer
CNS
Study Phase
Phase 3
Study Completion Date
2008
NCT00689221Uploaded 12-15-2020
Available for Download
PDS UID: Glioma_EMDSero_2008_441
N/A
Provider Information
Provider Data DescriptionThe primary objective of this study is to assess whether overall survival time in subjects receiving 2000 mg cilengitide in combination with standard treatment (TMZ with concomitant RTX, followed by TMZ maintenance therapy: TMZ/RTX?TMZ) is statistically significantly prolonged compared to subjects receiving standard treatment only (TMZ/RTX?TMZ). Only subjects with newly diagnosed GBM and tumors with methylated MGMT gene promoter will be randomized. Secondary objective is to investigate the Progression Free Survival (PFS). PFS will be assessed by the IRC according to the Macdonald criteria in an independent and blinded manner (details specified in the IRC charter). This will provide an objective, unbiased review of the eligible subject population based on the baseline assessment of the disease and the benefit of the respective study treatment.
SponsorEMD Serono
Data ProviderEMD Serono
Partial set or SubsetOriginal Data
Patients in dataset545
# of Patients Control273
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wqh9-tx27
CDISC StandardSDTM
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeRadiation, Drug
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
Files:
PROTOCOLCTP_EMD121974-011_final_redacted.pdf
CRFblankcrf.pdf
DATA DICTIONARYdatadict.xpt
DATA SUMMARYDescriptive_Stats_EMD121974_011.xlsx
DATA SUMMARYProc Contents Data Dictionary EMD121974_011.pdf
DATA (COMPARATOR ARM)DATA_XPT.zip
DATA (COMPARATOR ARM)DATA_SAS.zip
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