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Type(s) of Cancer
Gastric
Study Phase
Phase 3
Study Completion Date
March 2012
NCT00678535Uploaded 04-17-2015
Available for Download
PDS UID - Gastric_MerckKG_2008_130
Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction
Linked Data
PDS UID - Gastric_Multipl_2008_415Go to Study
Enhancing the Analytic Capacity of Gastric_MerckKG_2008_130 using a Statistical Linkage Method to Append Socioeconomic and Health Care Access Variables from the Medical Expenditure Panel Survey
Provider Information
Provider Data DescriptionPrimary objective: To demonstrate superiority of XP chemotherapy regimen plus cetuximab versus XP alone as first-line treatment for advanced gastric cancer in terms of PFS Secondary objectives: To assess cetuximab + XP versus XP alone with respect to: OS; overall response; QoL; safety
SponsorMerck KGaA
Data ProviderEMD Serono
Partial set or SubsetN/A
Patients in dataset882
# of Patients Control436
# of Patients Experimental436
DOIN/A
CDISC StandardSAS raw datasets
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.
ConditionsGastric Cancer
Intervention TypeDrug: Cetuximab
Drug: Capecitabine
Drug: Cisplatin
Drug(s)Drug: Cetuximab
Drug: Capecitabine
Drug: Cisplatin
Total Enrolled904
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionCetuximab plus Capecitabine plus Cisplatin - Experimental
Capecitabine plus Cisplatin - Active Comparator
Secondary ID2007-004219-75
PubMed (PMID)NA
Collaborator(s)NA
Region(s)Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Chile
China
Czech Republic
France
Germany
Greece
Hong Kong
Hungary
Israel
Italy
Japan
Korea, Republic of
Poland
Portugal
Romania
Russian Federation
Spain
Taiwan
United Kingdom
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files:
PROTOCOLEMR 200048-052_EXPAND_Redacted Clinical Study Protocol.pdf
CRFEMR200048-052_Expand_SAS annotated eCRF_.pdf
DATA DICTIONARYData Dictionary.pdf
DATA (COMPARATOR ARM)EMR200048-052_Expand_Raw Data control arm.zip
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