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

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 Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: FerInject; Drug: Ferro sanol

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Klinikum Aschaffenburg
  • Bayreuth, Germany, 85445
    • Klinikum Bayreuth
  • Bochum, Germany, 44791
    • Augusta-Krankenanstalt gGmbH
  • Bochum, Germany, 44892
    • Medizinische Universitaetsklinik Bochum
  • Dresden, Germany, 01067
    • Krankenhaus Dresden-Friedrichstadt
  • Dresden, Germany, 01307
    • Universitätsklinikum Dresden
  • Essen, Germany, 45136
    • Kliniken Essen Mitte
  • Frankfurt am Main, Germany, 60590
    • Universitatsklinikum Frankfurt
  • Halle, Germany, 06120
    • Universitätsklinik Halle-Wittenberg
  • Hamburg, Germany, 20246
    • Universitätskrankenhaus Eppendorf
  • Heidelberg, Germany, 69120
    • NCT Heidelberg
  • Koblenz, Germany, 56068
    • Gemeinschaftsklinikum Mittelrhein GmbH
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Munich, Germany, 81675
    • Klinikum rechts der Isar
  • Munich, Germany, 81925
    • Klinikum Bogenhausen
  • Riesa, Germany, 01589
    • Elblandklinikum Riesa
  • Saarbrucken, Germany, 66113
    • Caritas Klinikum St. Theresia
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60488
      • Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: iron deficiency anemia; MCRC; iron substitution
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Colorectal Neoplasms; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: FERINJECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared.