Effect of intravenous replenishment of iron in preoperative management of anemia in patients with colon cancer: RIPAC-trial

Phase 1

• Conditions: 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: 20.0Level: LLTClassification code 10009964Term: Colon carcinoma stage 0System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004213-41-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-06
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified