E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with anemia that undergo curative surgery in case of a colorectal carcinoma |
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E.1.1.1 | Medical condition in easily understood language |
Patients with anemia that undergo surgery in case of bowel cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim is to determine the efficiency of preoperative intravenous iron suppletion in comparison with the standard peri-operative oral substitution in anemic patients with colorectal cancer. |
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E.2.2 | Secondary objectives of the trial |
Secondary aims of the trial: - To analyze the effect of preoperative intravenous iron therapy on postoperative morbidity, length of stay, quality of life and fatigue - To analyze the effect of preoperative intravenous iron therapy on amount of blood transfusions needed. - To determine the cost effectiveness of preoperative iron substitution in comparison with oral substitution.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Colorectal carcinoma - Laparoscopic or open segment resection or a low anterior resection - Iron deficiency anemia: Hb <7,5mmol/l (12 g/dl) for women and Hb <8 mmol/l (13 g/dl) for men en TSAT<20% - Age 18 years or older - Written informed consent for study participation
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E.4 | Principal exclusion criteria |
- Palliative surgery / metastasized disease - Received blood transfusion within one month before screening - Serum ferritin ≥ 800 µg/L - Pregnancy - Preoperative chemoradiation (Short 5x5gy = no exclusion) - 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 anemia with indication for blood transfusion - Hereditary Heamochromatosis - Thalassemia - Hemolytic anemia/ chronic hemolysis
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E.5 End points |
E.5.1 | Primary end point(s) |
- Percentage of patients with normalization of HB-level from start treatment to day of surgery. (HB > 12g/dl (7.5mmol/L) for women and HB >13 g/dl (8.0mmol/L) for men |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At day prior to surgery or day of surgery
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E.5.2 | Secondary end point(s) |
- Change in morbidity score (Clavien-Dindo classification). - Total change from baseline HB-level at preoperation and postoperative day 1, at 1,4,8, and 12 weeks - Change in baseline in other iron/hematological parameters (i.e. TSAT, ferritin, CRP) at pre-operation, at day 1 and at 1, 4, 8 and 12 weeks post-operative. - Change from baseline in health-related QoL - Change from baseline in fatigue scores - Amount of blood transfusions needed |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoints will be evaluated at postoperative day 1 at and at 1, 4, 8, 12, and 36 weeks posteroperative. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS (six months from initial operation) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |