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Brief Title: Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
Official Title: Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
Study ID: NCT02469480
Brief Summary: Iron deficiency has a high prevalence in colorectal cancer patients ranging at ca. 60%. About 70% of these patients suffer from iron deficiency anemia (IDA) which adds both physical and cognitive impediments to an already straining chemotherapy. Moreover, a chronic disease like cancer often results in a reduced availability of iron for the body. In clinical practice iron substitution is usually administered orally. Due to low resorption rates, frequent gastric side effects and thus poor patient compliance a parenteral substitution seems to be a better option in terms of efficacy. In the framework of a randomized multicenter clinical trial ('FerInject') a comparison of efficacy parameters of parenteral vs. oral iron substitution will now be conducted in order to identify the best treatment form for clinical practice in oncology. Furthermore detailed quality of life-data (QoL) will be collected in both treatment arms for effect comparison.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research, Frankfurt am Main, Hesse, Germany
Klinikum Aschaffenburg, Aschaffenburg, , Germany
Klinikum Bayreuth, Bayreuth, , Germany
Augusta-Krankenanstalt gGmbH, Bochum, , Germany
Medizinische Universitaetsklinik Bochum, Bochum, , Germany
Krankenhaus Dresden-Friedrichstadt, Dresden, , Germany
Universitätsklinikum Dresden, Dresden, , Germany
Kliniken Essen Mitte, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt am Main, , Germany
Universitätsklinik Halle-Wittenberg, Halle, , Germany
Universitätskrankenhaus Eppendorf, Hamburg, , Germany
NCT Heidelberg, Heidelberg, , Germany
Gemeinschaftsklinikum Mittelrhein GmbH, Koblenz, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Klinikum rechts der Isar, Munich, , Germany
Klinikum Bogenhausen, Munich, , Germany
Elblandklinikum Riesa, Riesa, , Germany
Caritas Klinikum St. Theresia, Saarbrucken, , Germany