Clinical trial · Interventional
Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia
Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the anemia and the assess the effect of preoperative iron on morbidity, postoperative recovery and quality of life. Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with intravenous iron will lead to a higher percentage of patients with normalization of Hb-level (\> 12 g/dl (7.5 mmol/l) for women and \> 13 g/dl (8 mmol/l) for men), which potentially reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be more cost effective compared to current practice with oral substitution of iron.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ferric(III)carboxymaltose | Drug | — | UNRESOLVED |
| Ferrous fumarate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ferrous fumarate
- description
- Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
- interventionNames
- Drug: Ferrous fumarate
- type
- ACTIVE_COMPARATOR
- label
- ferric(III)carboxymaltose
- description
- Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered
- interventionNames
- Drug: ferric(III)carboxymaltose
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * M0-stage Colorectal carcinoma * Laparoscopic or open segmental colonic resection or (low) anterior resection * Iron deficiency anaemia: Hb \<7,5 mmol/l (12 g/dl) for women and Hb \< 8 mmol/l (13 g/dl) for men and TSAT\<20% * Age 18 or older * Written informed consent for study participation Exclusion Criteria: * Palliative surgery / metastasized disease * Received blood transfusion within one month before screening * Serum ferritin ≥ 800 µg/L * Pregnancy * Preoperative chemoradiation (Short course radiotherapy (5x5 Gy) = no exclusion) * Contraindication for the use of ferric(III)carboxymaltose or ferrofumarate * ASA classification \> 3 * Use of erythropoietin stimulating agents within three months before screening * Chronic kidney disease (GFR \< 30ml/min/m) * Myelodysplastic syndrome * Severe anaemia with indication for blood transfusion * Elevated liver enzymes (more than three times normal value) * Hereditary Hemochromatosis * Thalassemia * Haemolytic anaemia/ chronic haemolysis
References
Publications (2)
- DERIVEDTalboom K, Borstlap WAA, Roodbeen SX, Bruns ERJ, Buskens CJ, Hompes R, Tytgat KMAJ, Tuynman JB, Consten ECJ, Heuff G, Kuiper T, van Geloven AAW, Veldhuis GJ, van der Hoeven JAB, Gerhards MF, Sietses C, Spinelli A, van de Ven AWH, van der Zaag ES, Westerterp M, van Westreenen HL, Dijkgraaf ML, Juffermans NP, Bemelman WA; FIT collaborative group. Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial. Lancet Haematol. 2023 Apr;10(4):e250-e260. doi: 10.1016/S2352-3026(22)00402-1. Epub 2023 Feb 27. PMID 36863386
- DERIVEDBorstlap WAA, Buskens CJ, Tytgat KMAJ, Tuynman JB, Consten ECJ, Tolboom RC, Heuff G, van Geloven N, van Wagensveld BA, C A Wientjes CA, Gerhards MF, de Castro SMM, Jansen J, van der Ven AWH, van der Zaag E, Omloo JM, van Westreenen HL, Winter DC, Kennelly RP, Dijkgraaf MGW, Tanis PJ, Bemelman WA. Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients. BMC Surg. 2015 Jun 28;15:78. doi: 10.1186/s12893-015-0065-6. PMID 26123286