Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
NCT ID: NCT02469480
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2015-03-31
2020-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia
NCT01701310
Intravenous Iron: Measuring Response in Anemic Surgical Patients
NCT02057471
Intravenous Iron Injection in Cancer Patients With Anemia
NCT04187716
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients
NCT02599012
Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients
NCT03565354
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FERRIC CARBOXYMALTOSE
max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
FerInject
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
ferro sanol(R) duodenal 100 mg
200 mg ferro sanol per day over 12 weeks
Ferro sanol
200 mg ferro sanol per day over 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FerInject
FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
Ferro sanol
200 mg ferro sanol per day over 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Krankenhaus Nordwest gGmbH - Institut of Clinical Cancer Research
Frankfurt am Main, Hesse, Germany
Klinikum Aschaffenburg
Aschaffenburg, , Germany
Klinikum Bayreuth
Bayreuth, , Germany
Augusta-Krankenanstalt gGmbH
Bochum, , Germany
Medizinische Universitaetsklinik Bochum
Bochum, , Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, , Germany
Universitätsklinikum Dresden
Dresden, , Germany
Kliniken Essen Mitte
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitätsklinik Halle-Wittenberg
Halle, , Germany
Universitätskrankenhaus Eppendorf
Hamburg, , Germany
NCT Heidelberg
Heidelberg, , Germany
Gemeinschaftsklinikum Mittelrhein GmbH
Koblenz, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Klinikum rechts der Isar
Munich, , Germany
Klinikum Bogenhausen
Munich, , Germany
Elblandklinikum Riesa
Riesa, , Germany
Caritas Klinikum St. Theresia
Saarbrücken, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FERINJECT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.