M0-stage colon carcinoma with iron deficiency anemia defined by a Hb lower than 13 g/dl in men and 12g/dl in women with a transferrin saturation lower than 20% MedDRA version: 20.0 Level: LLT Classification code 10009964 Term: Colon carcinoma stage 0 System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Injectafer
Product Name: Injectafer
Pharmaceutical Form: Infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with a M0-stage colon carcinoma who are scheduled for segmental colonic resection • Patients with a Hb higher than 6.5 g/dl or 7.5 g/dl in patients with cardiac disease at moment of diagnosis • Patients with a proven iron deficiency anemia defined by a Hb lower than 13g/dl in men and 12g/dl in women with a transferrin saturation lower than 20%. • Obtained informed consent • =18 years; female or male Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: • The period between diagnosis and surgery is less than two weeks • Hemochromatosis, iron overload, defined as TSAT > 45% • Known hypersensitivity to Injectafer® • Metastatic colon disease • Patients not suitable for surgery due to age or comorbidities • Pregnancy, lactation or woman of childbearing potential who don’t use an effective method of contraception • Administration of IV iron/oral iron/ESA in the past three months before inclusion • Administration of blood transfusion in the past month before inclusion • Chronic kidney disease with a eGFR < 30 ml/min • Hematological disorders as a cause of anemia (myelodysplastic syndrome, leukemia, chronic hemolysis) • Vitamin B12 and/or serum folate deficiency • Patients undergoing endoscopic excision of a (rectal) carcinoma (EMR/ESD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the increase in preoperative Hb after intravenous iron substitution compared with no iron substitution in patients with colon cancer and iron deficiency anemia who are eligible for surgery. ;Secondary Objective: 2. To investigate the need for perioperative ABT after intravenous iron substitution compared with no iron substitution in patients with colon cancer and iron deficiency anemia who are eligible for surgery. 3. To investigate the rate of postoperative morbidity after intravenous iron substitution compared with no iron substitution in patients with colon cancer and iron deficiency anemia who are eligible for surgery. 4. To investigate the quality of life 30 days after surgery after intravenous iron substitution compared with no iron substitution in patients with colon cancer and iron deficiency anemia who are eligible for surgery. ;Primary end point(s): Mean Hb increase at moment of surgery ;Timepoint(s) of evaluation of this end point: day of surgery/1 or 2 days before surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of patients that need perioperative (interval: day of surgery until 7 days postoperative) blood transfusion 2. Postoperative morbidity measured by the The Clavien-Dindo classification 3. Postoperative morbidity measured by length of hospital stay 4. Postoperative quality of life 30 days after surgery measured by the EORTC QLQ-C30 ;Timepoint(s) of evaluation of this end point: 1. 1 week after surgery 2. 1 week and 1 month after surgery 3. 1 week and 1 month after surgery 4. 1 month after surgery | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Unit
Health, Innovation and Research Institute
Outcome results
None listed