Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Intravenous Ferric Carboxymaltose vs. Oral Iron Substitution in Patients With Metastatic Colorectal Cancer (CRC) and Iron Deficiency Anemia: a Randomized Multicenter Treatment Optimization Study.
