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Type(s) of Cancer
Esophageal
Study Phase
Phase 3
Study Completion Date
March 2012
NCT00678535Uploaded 05-18-2020
Available for Download
PDS UID: Gastric_Multipl_2008_415
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 DescriptionThis data enhancement project seeks to further advance the mission of the PDS platform by enabling new explorations into the potential influence of health care access, socioeconomic factors, and health behaviors on the patient-level efficacy and outcomes data contained in the PDS online service. This was achieved using a statistical linkage method in which patient-level records from PDS dataset, Gastric_MerckKG_2008_130, were matched with like cancer survivors from the nationally representative Medical Expenditure Panel Survey (MEPS). Linkage criteria were based on age, sex, race, and a quality of life assessment called the EQ-5D index score. The use of the EQ-5D score as a linkage criterion reduces the multitude of many-to-many exact matches that would have occurred using only age, race, and sex. The addition of the MEPS data to the patient-level data within the PDS enclave will facilitate hypothesis-generating research efforts that explore the level of variation in patient outcomes potentially attributable to differentials in access to basic health care services and their utilization, to socioeconomic characteristics, and to health behaviors and preferences. It will support exploratory analyses designed to examine questions such as How are variations in cancer patients' access to health care and income impacting patient outcomes in specific phase III clinical trials? What variations in patient outcomes are associated with specific demographic, socioeconomic, and health-related factors? Are the demographic characteristics of those cancer patients enrolled in specific phase III clinical trials comparable to cancer patients with the same disease in the general population?
SponsorResearcher Curated
Data ProviderRTI International
Partial set or SubsetComposite
Patients in dataset436
# of Patients Control0
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/m157-nb03
CDISC StandardN/A
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)N/A
Collaborator(s)N/A
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 Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLLinked Gastric_MerckKG_2008_130 Documentation.docx
CRFDataset Contents and Variable Crosswalk.xlsx
DATA DICTIONARYPDS_DATA_PROFILE_CREATED_130.xlsx
DATA SUMMARYProc Contents Data Dictionary Linked_Gastric_MerckKG_2008_130.pdf
DATA SUMMARYDescriptive_Stats_Linked_Gastric_MerckKG_2008_130.xlsx
DATA (COMPARATOR ARM)linked_gastric130.sas7bdat
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