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Metastatic Colorectal CancerPhase 2NCT02469480

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

A Phase 2 study testing FerInject and Ferro sanol in people with Metastatic Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 18 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
FerInject and Ferro sanol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
18 sitesGermany
Study dates
Mar 2015to Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • Klinikum Bayreuth

    Bayreuth, 85445

  • Augusta-Krankenanstalt gGmbH

    Bochum, 44791

  • Medizinische Universitaetsklinik Bochum

    Bochum, 44892

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, 01067

  • Universitätsklinikum Dresden

    Dresden, 01307

  • Kliniken Essen Mitte

    Essen, 45136

  • Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research

    Frankfurt am Main, Hesse, 60488

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsklinik Halle-Wittenberg

    Halle, 06120

  • Universitätskrankenhaus Eppendorf

    Hamburg, 20246

  • NCT Heidelberg

    Heidelberg, 69120

  • Gemeinschaftsklinikum Mittelrhein GmbH

    Koblenz, 56068

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Klinikum rechts der Isar

    Munich, 81675

  • Klinikum Bogenhausen

    Munich, 81925

  • Elblandklinikum Riesa

    Riesa, 01589

  • Caritas Klinikum St. Theresia

    Saarbrücken, 66113

Other trials in Germany

About this 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.

Being tested
FerInject, Ferro sanol
Keywords
MCRC, iron substitution, iron deficiency anemia
Medical subject headings
Colorectal Neoplasms, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FerInjectDrug

    FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).

  • Ferro sanolDrug

    200 mg ferro sanol per day over 12 weeks

Study groups in NCT02469480
Study groupRoleWhat they receive
FERRIC CARBOXYMALTOSEExperimentalmax. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
Receives: Drug: FerInject
ferro sanol(R) duodenal 100 mgActive comparator200 mg ferro sanol per day over 12 weeks
Receives: Drug: Ferro sanol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rise or normalization of hemoglobin

    Measured: 12 weeks

Secondary outcomes (16)

  1. Fatigue as measured by EORTC-QLQ-FA13

    Measured: 12 weeks

  2. Quality of life as measured by EORTC-C30

    Measured: 12 weeks

  3. Handgrip strength as measured by Hydraulic Hand Dynamometer

    Measured: 12 weeks

  4. Number of allogenic blood transfusions (in total and per patient)

    Measured: 12 weeks

  5. Time until rise or normalisation of hemoglobin

    Measured: 12 weeks

  6. Genesis of the iron deficiency anemia

    Measured: 12 weeks

  7. Number of therapy with recombinant erythropoietin

    Measured: 12 weeks

  8. Dose of therapy with recombinant erythropoietin

    Measured: 12 weeks

  9. Duration of therapy with recombinant erythropoietin

    Measured: 12 weeks

  10. Inflammatory parameters

    Measured: 12 weeks

  11. Influence nutritional status on iron deficiency anemia as measured by Nutritional Risk Screening (NRS 2002)

    Measured: 12 weeks

  12. Influence nutritional status on therapy success as measured by Nutritional Risk Screening (NRS 2002)

    Measured: 12 weeks

  13. Tolerance

    Measured: 12 weeks

  14. 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.

    Measured: 12 weeks

  15. Dropout rate due to toxicity or patient will

    Measured: 12 weeks

  16. Overall survival

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2020
  4. Study completionAug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02469480
Sponsor's protocol ID
FERINJECT
Status last verified
Oct 2020
First submitted
13 May 2015
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FerInject and Ferro sanol in people with Metastatic Colorectal Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 18 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rise or normalization of hemoglobin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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