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 - IVICA: Intravenous iron in colorectal cancer associated anaemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002185-21-GB

Enrollment

116

Registered

2011-09-05

Start date

2011-09-15

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The medical condition to be investigated is anaemia (low blood count) in pre-operative patients with colorectal cancer. MedDRA version: 14.0 Level: LLT Classification code 10005835 Term: Blood transfusion System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ferrous sulphate Product Name: Ferrous sulphate Pharmaceutical Form: Tablet INN or Proposed INN: Iron Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pre-operative patients with colorectal adenocarcinoma 2) Aged 18 to 75 years 3) Anaemic at point of diagnosis of colorectal adenocarcinoma (haemoglobin 1g/dL below the local laboratory lower limit of normal reference range) 4) Medically fit for surgery Are the trial subjects under 18? no Number of subjects for this age range: 116 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1) Pregnant and breast feeding females 2) Previous gastric, small bowel or colorectal surgery (where more than 50% of the stomach or small bowel has been resected) 3) Current chemotherapeutic treatment 4) Known previous anaemia not attributable to colorectal adenocarcinoma (e.g. due to an inflammatory disorder) 5) Features necessitating urgent surgery (e.g. obstructive symptoms) 6) Symptomatic anaemia necessitating urgent blood transfusion (e.g. cardiovascular compromise)

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal research question is can we reduce the need for peri-operative allogeneic blood transfusion in the treatment group (intravenous ferric carboxymaltose) compared to the control group (oral ferrous sulphate)?;Secondary Objective: The secondary research questions are: a) Can we improve peri- and post-operative outcomes, reduce post-operative length of stay and improve post-operative quality of life in the treatment group compared to the control group? b) Can we use pre-treatment levels of markers of iron metabolism to predict which patients are more likely to respond to treatment with oral ferrous sulphate or intravenous ferric carboxymaltose in order to aid treatment decisions? c) Does oral iron affect the expression of iron transport proteins in intestinal cells that can result in increased risk of progression of cancer? d) Does oral iron affect the signalling activity on colonic cells that can increase risk of progression of cancer?;Primary end point(s): Rate of blood transfusion pre and intra-operatively.;Timepoint(s) of evaluation of this end point: Pre-operativePost-operative (Day 2, Week 6-8)	—

Measure

Time frame

Main Objective: The principal research question is can we reduce the need for peri-operative allogeneic blood transfusion in the treatment group (intravenous ferric carboxymaltose) compared to the control group (oral ferrous sulphate)?;Secondary Objective: The secondary research questions are: a) Can we improve peri- and post-operative outcomes, reduce post-operative length of stay and improve post-operative quality of life in the treatment group compared to the control group? b) Can we use pre-treatment levels of markers of iron metabolism to predict which patients are more likely to respond to treatment with oral ferrous sulphate or intravenous ferric carboxymaltose in order to aid treatment decisions? c) Does oral iron affect the expression of iron transport proteins in intestinal cells that can result in increased risk of progression of cancer? d) Does oral iron affect the signalling activity on colonic cells that can increase risk of progression of cancer?;Primary end point(s): Rate of blood transfusion pre and intra-operatively.;Timepoint(s) of evaluation of this end point: Pre-operativePost-operative (Day 2, Week 6-8)

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Secondary

Measure	Time frame
Secondary end point(s): Levels of haemoglobin and haematinic markers (full blood count, ferritin, iron, transferrin, transferrin saturation, erythropoietin).;Timepoint(s) of evaluation of this end point: These will be measured at a point before administration of intravenous iron or oral ferrous sulphate (at least two weeks pre-operatively), immediately pre-operatively, day two post-operatively and six weeks post-operatively.	—

Measure

Time frame

Secondary end point(s): Levels of haemoglobin and haematinic markers (full blood count, ferritin, iron, transferrin, transferrin saturation, erythropoietin).;Timepoint(s) of evaluation of this end point: These will be measured at a point before administration of intravenous iron or oral ferrous sulphate (at least two weeks pre-operatively), immediately pre-operatively, day two post-operatively and six weeks post-operatively.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026