Spots Global Cancer Trial Database for Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
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Trial Identification
Brief Title: Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer
Official Title: Multicenter Phase II-trial to Investigate Safety and Efficacy of an Adjuvant Therapy With Gemcitabine and Erbitux® in Patients With R0 or R1 Resected Pancreatic Cancer
Study ID: NCT00395252
Conditions
Interventions
Study Description
Brief Summary: This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.
Detailed Description: Available study data indicated a possible benefit from adjuvant chemotherapy for patients with resected pancreatic cancer. The optimal therapy regimen has yet to be determined. Based on the experiences with cetuximab (Erbitux®)and gemcitabine in advanced pancreatic cancer and with gemcitabine as adjuvant therapy, the aim of this study was to evaluate the feasibility of the combined treatment of cetuximab and gemcitabine in patients with R0 or R1-resectable pancreatic cancer and to evaluate if the disease free survival can be increased by the addition of an EGFR-targeted therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Interdisziplinäres Tumorzentrum (Comprehensive Cancer Center), Fulda, , Germany
Nationales Centrum für Tumorerkrankungen (NCT), Universitätsklinikum Heidelberg, Heidelberg, , Germany
Klinik für Innere Medizin II, Klinikum der Universität Jena, Jena, , Germany
Allgemein-, Viszeral- und Thoraxchirurgie, Klinikum Kassel, Kassel, , Germany
Abt. für Chirurgie, Universitätsklinikum Mannheim gGmbH, Mannheim, , Germany
Klinikum Giessen und Marburg, Standort Marburg, Marburg, , Germany
II Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, TU München, Munich, , Germany
Klinik- und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg, Regensburg, , Germany
Contact Details
Name: Thomas M Gress, Prof.Dr. med
Affiliation: Klinik für Gastroenterologie, Endokrinologie und Stoffwechsel, University of Marburg
Role: PRINCIPAL_INVESTIGATOR
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