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 Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: FerInject
* Drug: Ferro sanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic or inoperable colorectal carcinoma. No curative therapy available. Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study. Iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation < 20 % and/or serum ferritin < 20 ng/ml Male and female patients aged ≥ 18 years; maturity ECOG ≤ 2 Written informed consent Life expectancy > 6 months Body weight ≥ 40 kg Exclusion Criteria: Oral or intravenous iron substitution within the last 4 weeks Age < 18 years or body weight < 40 kg Absorption dysfunction due to short bowel syndrome or after gastric resection Therapy with recombinant erythropoietin within the last 4 weeks Chronic diarrhea Chronic inflammatory bowel disease Ferritin > 800 mg/dl at baseline Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex Known vitamin B12 or folic acid anemia Necessary total parenteral nutrition Participation in another interventional study Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FERRIC CARBOXYMALTOSE<br>max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week). | Drug: FerInject<br>* FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).<br>|
| Active Comparator: ferro sanol(R) duodenal 100 mg<br>200 mg ferro sanol per day over 12 weeks | Drug: Ferro sanol<br>* 200 mg ferro sanol per day over 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rise or normalization of hemoglobin |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 12 weeks | 
| Dropout rate due to toxicity or patient will |  | 12 weeks | 
| Overall survival |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCRC, iron substitution, iron deficiency anemia