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

October 15, 2020 updated by: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Universitätsklinikum 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rise or normalization of hemoglobin
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatigue as measured by EORTC-QLQ-FA13
Time Frame: 12 weeks
12 weeks
Quality of life as measured by EORTC-C30
Time Frame: 12 weeks
12 weeks
Handgrip strength as measured by Hydraulic Hand Dynamometer
Time Frame: 12 weeks
12 weeks
Number of allogenic blood transfusions (in total and per patient)
Time Frame: 12 weeks
12 weeks
Time until rise or normalisation of hemoglobin
Time Frame: 12 weeks
12 weeks
Genesis of the iron deficiency anemia
Time Frame: 12 weeks
12 weeks
Number of therapy with recombinant erythropoietin
Time Frame: 12 weeks
12 weeks
Dose of therapy with recombinant erythropoietin
Time Frame: 12 weeks
12 weeks
Duration of therapy with recombinant erythropoietin
Time Frame: 12 weeks
12 weeks
Inflammatory parameters
Time Frame: 12 weeks
12 weeks
Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)
Time Frame: 12 weeks
12 weeks
Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)
Time Frame: 12 weeks
12 weeks
Tolerance
Time Frame: 12 weeks
12 weeks
Incidence and severity of adverse events
Time Frame: 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.
12 weeks
Dropout rate due to toxicity or patient will
Time Frame: 12 weeks
12 weeks
Overall survival
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FERINJECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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