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Gastric

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

Unique Data Set IDGastric_MerckKG_2008_130
DownloadableYes
SponsorMerck KGaAData ProviderEMD SeronoTotal Study Enrolled Patients904Comparator (Control) Arm Enrolled Patients449RandomizationYesClinicalTrial.gov IDNCT00678535ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/study/NCT00678535?term=EMR+200048-052&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, DrugData Set TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

The 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.

Data Summary

Control arms data files include medical history, eligibility, demography, efficacy, safety, concomitant medications, quality of life, laboratory assessment

Study Objectives

Primary 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

Outcome Measures

- Progression-free Survival (PFS) - Overall Survival (OS) - Best Overall Response (BOR) Rate - Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) - Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire - Safety - Number of Participants With Adverse Events (AEs)

Available Downloads:

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

PROTOCOL: EMR 200048-052_EXPAND_Redacted Clinical Study Protocol.pdf

CRF: EMR200048-052_Expand_SAS annotated eCRF_.pdf

DATA DICTIONARY: Data Dictionary.pdf

DATA (COMPARATOR ARM): EMR200048-052_Expand_Raw Data control arm.zip