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Sponsored by: |
Merck KGaA |
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Information provided by: | EMD Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00678535 |
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with XP chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including GEJ adenocarcinoma, in terms of PFS.
Secondary objectives are to assess cetuximab + XP versus XP alone with respect to overall survival, overall tumor response, quality of life and safety.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: Cetuximab + Capecitabine and Cisplatin Drug: Capecitabine and Cisplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official 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 |
Estimated Enrollment: | 870 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Experimental drug + chemotherapy approved
|
Drug: Cetuximab + Capecitabine and Cisplatin
q week + XP q 3 weeks
|
B: Active Comparator
Chemotherapy approved
|
Drug: Capecitabine and Cisplatin
q 3 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Isil Montaner | 34-93-565-5578 | imontaner@merck.es |
Austria | |
Research Site | Not yet recruiting |
Wien, Austria | |
Research Site | Not yet recruiting |
Zams, Austria | |
Belgium | |
Research Site | Not yet recruiting |
Bonheiden, Belgium | |
Research Site | Not yet recruiting |
Bruxelles, Belgium | |
Czech Republic | |
Research Site | Recruiting |
Brno, Czech Republic | |
Research Site | Not yet recruiting |
Hradec Králové, Czech Republic | |
Germany | |
Research Site | Not yet recruiting |
Berlin, Germany | |
Research Site | Not yet recruiting |
Giessen, Germany | |
Research Site | Recruiting |
Heidelberg, Germany | |
Research Site | Not yet recruiting |
Schäbisch Hall, Germany | |
Research Site | Not yet recruiting |
Hamburg, Germany | |
Research Site | Not yet recruiting |
München, Germany | |
Research Site | Recruiting |
Mainz, Germany | |
Research Site | Not yet recruiting |
Weilheim, Germany | |
Research Site | Not yet recruiting |
Regensburg, Germany | |
Research Site | Recruiting |
Essen, Germany | |
Research Site | Not yet recruiting |
Dresden, Germany | |
Research Site | Not yet recruiting |
Troisdorf, Germany | |
Research Site | Not yet recruiting |
Timisoara, Germany | |
Hungary | |
Research Site | Recruiting |
Tatabanya, Hungary | |
Research Site | Not yet recruiting |
Kaposvar, Hungary | |
Korea, Democratic People's Republic of | |
Research Site | Recruiting |
Seoul, Korea, Democratic People's Republic of | |
Romania | |
Research Site | Not yet recruiting |
Cluj-Napoca, Romania | |
Research Site | Not yet recruiting |
Bucharest, Romania | |
Research Site | Recruiting |
Iasi, Romania | |
Spain | |
Research Site | Not yet recruiting |
Alicante, Spain | |
Research Site | Recruiting |
Santander, Spain | |
Research Site | Not yet recruiting |
Valencia, Spain | |
Taiwan | |
Research Site | Not yet recruiting |
Taipei, Taiwan | |
Research Site | Not yet recruiting |
Tainan, Taiwan |
Principal Investigator: | Florian Lordick, MD, PhD | National Center of Tumour Diseases (NCT), University of Heidelberg, Germany |
Responsible Party: | Merck KGaA ( Isil Montaner ) |
Study ID Numbers: | EMR 200048-052 |
Study First Received: | May 13, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00678535 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
1st line treatment for Gastric Cancer |
Capecitabine Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin Gastrointestinal Diseases |
Stomach Neoplasms Cetuximab Gastrointestinal Neoplasms Stomach cancer Adenocarcinoma |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |