Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
1 other identifier
interventional
64
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2015
Longer than P75 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 19, 2020
October 1, 2020
5.2 years
May 13, 2015
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rise or normalization of hemoglobin
12 weeks
Secondary Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (2)
FERRIC CARBOXYMALTOSE
EXPERIMENTALmax. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
ferro sanol(R) duodenal 100 mg
ACTIVE COMPARATOR200 mg ferro sanol per day over 12 weeks
Interventions
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research
Frankfurt am Main, Hesse, 60488, Germany
Klinikum Aschaffenburg
Aschaffenburg, 63739, Germany
Klinikum Bayreuth
Bayreuth, 85445, Germany
Augusta-Krankenanstalt gGmbH
Bochum, 44791, Germany
Medizinische Universitaetsklinik Bochum
Bochum, 44892, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, 01067, Germany
Universitätsklinikum Dresden
Dresden, 01307, Germany
Kliniken Essen Mitte
Essen, 45136, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitätsklinik Halle-Wittenberg
Halle, 06120, Germany
Universitätskrankenhaus Eppendorf
Hamburg, 20246, Germany
NCT Heidelberg
Heidelberg, 69120, Germany
Gemeinschaftsklinikum Mittelrhein GmbH
Koblenz, 56068, Germany
Universitätsmedizin Mannheim
Mannheim, 68167, Germany
Klinikum rechts der Isar
Munich, 81675, Germany
Klinikum Bogenhausen
Munich, 81925, Germany
Elblandklinikum Riesa
Riesa, 01589, Germany
Caritas Klinikum St. Theresia
Saarbrücken, 66113, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
June 11, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2020
Study Completion
August 1, 2020
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared.