Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia
FIT
Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients
2 other identifiers
interventional
198
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2014
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2014
CompletedFirst Posted
Study publicly available on registry
September 18, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 28, 2018
August 1, 2018
5 years
September 12, 2014
August 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Normalization of Hb-level.
Percentage of patients with normalization of Hb-level from start treatment until day of admission for surgery. (Hb \>12g/dl (7.5mmol/L) for women and Hb \>13 g/dl (8.0mmol/L) for men). Patient will be randomised after they visit the surgery outpatient clinic to discuss the treatment option for their colorectal carcinoma. Average time between this visit and surgery in the Netherlands is maximally 5 weeks. Patients on oral iron suppletion will start with the iron therapy on the day of the randomisation. For the patients that will receive intravenous iron an appointment will be made on the short-care unit to facilitate the infusion of the iron. The period between infusion and surgery should be longer than two weeks. Our primary endpoint: Percentage of patients with normalization of Hb-level. Will be measured at the day of admission before surgery. Which is one day prior to surgery. The Hb-level will be followed-up after surgery on postoperative day 1, day 7 and after 4,8 and 12 weeks.
From Baseline (date of randomisation) untill day of admission for surgery
Secondary Outcomes (1)
Difference in Morbidity score
postoperative at week 1, week 4, week 8 and week 12
Study Arms (2)
Ferrous fumarate
ACTIVE COMPARATORPatients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
ferric(III)carboxymaltose
ACTIVE COMPARATORPatients 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
Interventions
Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Palliative surgery / metastasized disease
- Received blood transfusion within one month before screening
- Serum ferritin ≥ 800 µg/L
- Pregnancy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander Ziekenhuis
Amersfoort, Netherlands
Academic Medical Center
Amsterdam, 1100DD, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Spaarne ziekenhuis
Amsterdam, Netherlands
VU medical center
Amsterdam, Netherlands
Unknown Facility
Amsterdam, Netherlands
Gelre Ziekenhuis
Apeldoorn, Netherlands
Albert Schweizer Ziekenhuis
Dordrecht, Netherlands
Tergooi ziekenhuis
Hilversum, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Related Publications (2)
Talboom 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: 36863386DERIVEDBorstlap 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: 26123286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
W. A Bemelman, Proffessor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 12, 2014
First Posted
September 18, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2019
Study Completion
December 1, 2019
Last Updated
August 28, 2018
Record last verified: 2018-08