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

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

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

...and 8 more locations

Outcomes

Primary Outcomes

Rise or normalization of hemoglobin

Time frame: 12 weeks

Secondary Outcomes

Fatigue as measured by EORTC-QLQ-FA13

Time frame: 12 weeks

Quality of life as measured by EORTC-C30

Time frame: 12 weeks

Handgrip strength as measured by Hydraulic Hand Dynamometer

Time frame: 12 weeks

Number of allogenic blood transfusions (in total and per patient)

Time frame: 12 weeks

Time until rise or normalisation of hemoglobin

Time frame: 12 weeks

Genesis of the iron deficiency anemia

Time frame: 12 weeks

Number of therapy with recombinant erythropoietin

Time frame: 12 weeks

Dose of therapy with recombinant erythropoietin

Time frame: 12 weeks

Duration of therapy with recombinant erythropoietin

Time frame: 12 weeks

Inflammatory parameters

Time frame: 12 weeks

Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)

Time frame: 12 weeks

Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)

Time frame: 12 weeks

Tolerance

Time frame: 12 weeks

Incidence and severity of adverse events

incidence and severity of adverse events according to CTCAE (Common Terminology Criteria for Adverse Events) Version 4 criteria as assessed at day 1, 8, 15, 36, 50 and 64 and at end of treatment.

Time frame: 12 weeks

Dropout rate due to toxicity or patient will

Time frame: 12 weeks

Overall survival

Time frame: 12 weeks