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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 JunctionUnique Data Set IDGastric_MerckKG_2008_130
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.
Control arms data files include medical history, eligibility, demography, efficacy, safety, concomitant medications, quality of life, laboratory assessment
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
- 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)
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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