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Spots Global Cancer Trial Database for Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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