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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: FerInject; Drug: Ferro sanol

• Registration Number: NCT02469480
• Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Primary Completion: 2020-05
• Study Completion: 2020-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FERRIC CARBOXYMALTOSE	FerInject	max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
ferro sanol(R) duodenal 100 mg	Ferro sanol	200 mg ferro sanol per day over 12 weeks

Primary Outcome Measures

Name	Time	Method
Rise or normalization of hemoglobin	12 weeks

Secondary Outcome Measures

Name	Time	Method
Fatigue as measured by EORTC-QLQ-FA13	12 weeks
Quality of life as measured by EORTC-C30	12 weeks
Handgrip strength as measured by Hydraulic Hand Dynamometer	12 weeks
Number of allogenic blood transfusions (in total and per patient)	12 weeks
Time until rise or normalisation of hemoglobin	12 weeks
Genesis of the iron deficiency anemia	12 weeks
Number of therapy with recombinant erythropoietin	12 weeks
Dose of therapy with recombinant erythropoietin	12 weeks
Duration of therapy with recombinant erythropoietin	12 weeks
Inflammatory parameters	12 weeks
Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)	12 weeks
Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)	12 weeks
Tolerance	12 weeks
Incidence and severity of adverse events	12 weeks	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.
Dropout rate due to toxicity or patient will	12 weeks
Overall survival	12 weeks

Trial Locations

Locations (18)

Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research; 🇩🇪 Frankfurt am Main, Hesse, Germany

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitätskrankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

NCT Heidelberg; 🇩🇪 Heidelberg, Germany

Krankenhaus Dresden-Friedrichstadt; 🇩🇪 Dresden, Germany

Caritas Klinikum St. Theresia; 🇩🇪 Saarbrucken, Germany

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

Augusta-Krankenanstalt gGmbH; 🇩🇪 Bochum, Germany

Medizinische Universitaetsklinik Bochum; 🇩🇪 Bochum, Germany

Kliniken Essen Mitte; 🇩🇪 Essen, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Universitätsklinik Halle-Wittenberg; 🇩🇪 Halle, Germany

Gemeinschaftsklinikum Mittelrhein GmbH; 🇩🇪 Koblenz, Germany

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Germany

Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Elblandklinikum Riesa; 🇩🇪 Riesa, Germany

Klinikum Bogenhausen; 🇩🇪 Munich, Germany