Back to resultsIntravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
FerInject
Ferro sanol
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Colorectal Cancer focused on measuring MCRC, iron substitution, iron deficiency anemia
Eligibility Criteria
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
Sites / Locations
- Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research
- Klinikum Aschaffenburg
- Klinikum Bayreuth
- Augusta-Krankenanstalt gGmbH
- Medizinische Universitaetsklinik Bochum
- Krankenhaus Dresden-Friedrichstadt
- Universitätsklinikum Dresden
- Kliniken Essen Mitte
- Universitätsklinikum Frankfurt
- Universitätsklinik Halle-Wittenberg
- Universitätskrankenhaus Eppendorf
- NCT Heidelberg
- Gemeinschaftsklinikum Mittelrhein GmbH
- Universitätsmedizin Mannheim
- Klinikum rechts der Isar
- Klinikum Bogenhausen
- Elblandklinikum Riesa
- Caritas Klinikum St. Theresia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FERRIC CARBOXYMALTOSE
ferro sanol(R) duodenal 100 mg
Arm Description
max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
200 mg ferro sanol per day over 12 weeks
Outcomes
Primary Outcome Measures
Rise or normalization of hemoglobin
Secondary Outcome Measures
Fatigue as measured by EORTC-QLQ-FA13
Quality of life as measured by EORTC-C30
Handgrip strength as measured by Hydraulic Hand Dynamometer
Number of allogenic blood transfusions (in total and per patient)
Time until rise or normalisation of hemoglobin
Genesis of the iron deficiency anemia
Number of therapy with recombinant erythropoietin
Dose of therapy with recombinant erythropoietin
Duration of therapy with recombinant erythropoietin
Inflammatory parameters
Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)
Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)
Tolerance
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.
Dropout rate due to toxicity or patient will
Overall survival
Full Information
NCT ID
NCT02469480
First Posted
May 13, 2015
Last Updated
October 15, 2020
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
1. Study Identification
Unique Protocol Identification Number
NCT02469480
Brief Title
Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
MCRC, iron substitution, iron deficiency anemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FERRIC CARBOXYMALTOSE
Arm Type
Experimental
Arm Description
max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
Arm Title
ferro sanol(R) duodenal 100 mg
Arm Type
Active Comparator
Arm Description
200 mg ferro sanol per day over 12 weeks
Intervention Type
Drug
Intervention Name(s)
FerInject
Intervention Description
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
Intervention Type
Drug
Intervention Name(s)
Ferro sanol
Intervention Description
200 mg ferro sanol per day over 12 weeks
Primary Outcome Measure Information:
Title
Rise or normalization of hemoglobin
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fatigue as measured by EORTC-QLQ-FA13
Time Frame
12 weeks
Title
Quality of life as measured by EORTC-C30
Time Frame
12 weeks
Title
Handgrip strength as measured by Hydraulic Hand Dynamometer
Time Frame
12 weeks
Title
Number of allogenic blood transfusions (in total and per patient)
Time Frame
12 weeks
Title
Time until rise or normalisation of hemoglobin
Time Frame
12 weeks
Title
Genesis of the iron deficiency anemia
Time Frame
12 weeks
Title
Number of therapy with recombinant erythropoietin
Time Frame
12 weeks
Title
Dose of therapy with recombinant erythropoietin
Time Frame
12 weeks
Title
Duration of therapy with recombinant erythropoietin
Time Frame
12 weeks
Title
Inflammatory parameters
Time Frame
12 weeks
Title
Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)
Time Frame
12 weeks
Title
Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)
Time Frame
12 weeks
Title
Tolerance
Time Frame
12 weeks
Title
Incidence and severity of adverse events
Description
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
Title
Dropout rate due to toxicity or patient will
Time Frame
12 weeks
Title
Overall survival
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research
City
Frankfurt am Main
State/Province
Hesse
ZIP/Postal Code
60488
Country
Germany
Facility Name
Klinikum Aschaffenburg
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Klinikum Bayreuth
City
Bayreuth
ZIP/Postal Code
85445
Country
Germany
Facility Name
Augusta-Krankenanstalt gGmbH
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Medizinische Universitaetsklinik Bochum
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Krankenhaus Dresden-Friedrichstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Kliniken Essen Mitte
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinik Halle-Wittenberg
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätskrankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
NCT Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Gemeinschaftsklinikum Mittelrhein GmbH
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Bogenhausen
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Elblandklinikum Riesa
City
Riesa
ZIP/Postal Code
01589
Country
Germany
Facility Name
Caritas Klinikum St. Theresia
City
Saarbrucken
ZIP/Postal Code
66113
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared.
Links:
URL
http://www.ikf-nordwest.de/home-studien.html?study=156
Description
Related Info
Learn more about this trial
Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
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