Clinical trial · Interventional
IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia
An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy
NCT01701310CI-TRIAL-00024497IVICAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention). It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.
Conditions
Conditions (2)
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 Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferric carboxymaltose | Drug | — | UNRESOLVED |
| Ferrous Sulphate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ferric carboxymaltose
- interventionNames
- Drug: Ferric carboxymaltose
- type
- ACTIVE_COMPARATOR
- label
- Ferrous Sulphate
- interventionNames
- Drug: Ferrous Sulphate
Primary outcomes (1)
- measure
- To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia
- timeFrame
- 0 - 6 to 12 weeks
- description
- To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Diagnosed with histologically proven colorectal adenocarcinoma. * Anemic at point of diagnosis of colorectal adenocarcinoma. (Haemoglobin values of \<12 g/dL for males and \<11 g/dL for females) * Medically fit for surgery. * Date of planned surgery is \>14 days from date of planned initiation of intervention (intravenous ferric carboxymaltose /oral ferrous sulphate). * Able and willing to comply with all study requirements. * Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion criteria: * Female participants who are pregnant, lactating or planning a pregnancy during the course of the study. * Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected) * Current chemotherapeutic treatment. * Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established inflammatory disorders or chronic renal disease). * Known haematological disease. * Features necessitating urgent surgery (e.g. obstructive symptoms). * Previous allergy to intravenous iron or related iron products. * Significant symptomatic anemia necessitating urgent transfusion (e.g. cardiovascular compromise) * Patients who are unable to consent. * Significant renal or hepatic impairment. * -Donation of blood during the study. * Participants who have participated in another research study involving an investigational product in the past 12 weeks * Prisoners and minors (\<18 years) * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.