E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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% |
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E.1.1.1 | Medical condition in easily understood language |
Colon cancer with iron deficiency anemia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009964 |
E.1.2 | Term | Colon carcinoma stage 0 |
E.1.2 | System Organ Class | 100000004864 |
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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 |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean Hb increase at moment of surgery |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
day of surgery/1 or 2 days before surgery |
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E.5.2 | 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
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E.5.2.1 | 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 |
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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 | No |
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 | No |
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 | No |
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) | No |
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 | 3 |
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 | No |
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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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 | |