Clinical trial NCT02469480: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: MCRC
iron substitution
iron deficiency anemia
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Metastatic or inoperable colorectal carcinoma. No curative therapy available.
2. Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study.
3. Iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation \< 20 % and/or serum ferritin \< 20 ng/ml
4. Male and female patients aged ≥ 18 years; maturity
5. ECOG ≤ 2
6. Written informed consent
7. Life expectancy \> 6 months
8. Body weight ≥ 40 kg

Exclusion Criteria:

1. Oral or intravenous iron substitution within the last 4 weeks
2. Age \< 18 years or body weight \< 40 kg
3. Absorption dysfunction due to short bowel syndrome or after gastric resection
4. Therapy with recombinant erythropoietin within the last 4 weeks
5. Chronic diarrhea
6. Chronic inflammatory bowel disease
7. Ferritin \> 800 mg/dl at baseline
8. Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex
9. Known vitamin B12 or folic acid anemia
10. Necessary total parenteral nutrition
11. Participation in another interventional study
12. Pregnancy or lactation

Primary outcomes:
measure: Rise or normalization of hemoglobin
timeFrame: 12 weeks
Secondary outcomes:
measure: Fatigue as measured by EORTC-QLQ-FA13
timeFrame: 12 weeks
measure: Quality of life as measured by EORTC-C30
timeFrame: 12 weeks
measure: Handgrip strength as measured by Hydraulic Hand Dynamometer
timeFrame: 12 weeks
measure: Number of allogenic blood transfusions (in total and per patient)
timeFrame: 12 weeks
measure: Time until rise or normalisation of hemoglobin
timeFrame: 12 weeks
measure: Genesis of the iron deficiency anemia
timeFrame: 12 weeks
measure: Number of therapy with recombinant erythropoietin
timeFrame: 12 weeks
measure: Dose of therapy with recombinant erythropoietin
timeFrame: 12 weeks
measure: Duration of therapy with recombinant erythropoietin
timeFrame: 12 weeks
measure: Inflammatory parameters
timeFrame: 12 weeks
measure: Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)
timeFrame: 12 weeks
measure: Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)
timeFrame: 12 weeks
measure: Tolerance
timeFrame: 12 weeks
measure: Incidence and severity of adverse events
timeFrame: 12 weeks
measure: Dropout rate due to toxicity or patient will
timeFrame: 12 weeks
measure: Overall survival
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research
state: Hesse
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Bochum
country: Germany
facility: Augusta-Krankenanstalt gGmbH
city: Bochum
country: Germany
facility: Medizinische Universitaetsklinik Bochum
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Essen
country: Germany
facility: Kliniken Essen Mitte
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Halle
country: Germany
facility: Universitätsklinik Halle-Wittenberg
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Eppendorf
city: Heidelberg
country: Germany
facility: NCT Heidelberg
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein GmbH
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Munich
country: Germany
facility: Klinikum rechts der Isar
city: Munich
country: Germany
facility: Klinikum Bogenhausen
city: Riesa
country: Germany
facility: Elblandklinikum Riesa
city: Saarbrucken
country: Germany
facility: Caritas Klinikum St. Theresia
Study officials:
References: