Comparison of two ways of iron intake for patients with colorectal cancer and iron deficiency.

Intravenous ferric carboxymaltose vs. oral iron substitution in patients with metastatic colorectal cancer (CRC) and iron deficiency anemia: a randomized multicenter treatment optimization study. - FERINJECT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000246-30-DE

Enrollment

Registered

2014-06-16

Start date

2014-09-30

Completion date

Unknown

Last updated

2020-08-10

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

Conditions

Iron deficiency anemia in patients with metastatic or inoperable colorectal cancer MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851

Interventions

Trade Name: Ferinject 50 mg Eisen/ml Product Name: Ferinject Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Metastatic or inoperable colorectal carcinoma. No curative therapy available. 2. Current palliative chemotherapy. Patients under conversion therapy must not be enrolled to this study. 3. Iron deficiency anemia: hemoglobin = 10.5 g/dl and transferrin saturation 6 months 8. Body weight = 40 kg 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 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: 1. Oral or intravenous iron substitution within the last 4 weeks 2. Age 800 mg/dl at baseline 8. Hypersensitivity or contraindication to ferric carboxymaltose or iron (II) glycine sulphate complex 9. Known vitamin B12 or folic acid anemia 10. Necessary total parenteral nutrition 11. Participation in another interventional study 12. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: Rise or normalization of hemoglobin;Secondary Objective: - Fatigue - Quality of life - Gradient of manual force - Number of allogenic blood transfusions (in total and per patient) - Time until rise or normalisation of hemoglobin - Genesis of the iron deficiency anemia - Number, dose and duration of therapy with recombinant erythropoietin - Inflammatory parameters - Influence nutritional status on iron deficiency anemia and therapy success - Tolerance and toxicity - Dropout rate due to toxicity or patient will - Overall survival;Primary end point(s): Rise of hemoglobin by 2g/dl or normalization (12g/dl);Timepoint(s) of evaluation of this end point: 12 weeks after baseline	—

Measure

Time frame

Main Objective: Rise or normalization of hemoglobin;Secondary Objective: - Fatigue - Quality of life - Gradient of manual force - Number of allogenic blood transfusions (in total and per patient) - Time until rise or normalisation of hemoglobin - Genesis of the iron deficiency anemia - Number, dose and duration of therapy with recombinant erythropoietin - Inflammatory parameters - Influence nutritional status on iron deficiency anemia and therapy success - Tolerance and toxicity - Dropout rate due to toxicity or patient will - Overall survival;Primary end point(s): Rise of hemoglobin by 2g/dl or normalization (12g/dl);Timepoint(s) of evaluation of this end point: 12 weeks after baseline

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Secondary

Measure	Time frame
Secondary end point(s): 1. Fatigue via EORTC-QLQ-FA13 (descriptive) 2. Quality of life via EORTC-QLQ-C30 (descriptive) 3. Manual force via Hydraulic Hand Dynamometer (descriptive) 4. Number of allogenic blood transfusions (total and number of patients); (descriptive) 5. Time to normalization of hemoglobin (descriptive) 6. Genesis of iron deficiency anemia: iron deficiency anemia in chronic diseased patients vs. absolute iron deficiency without chronic disease (explorative) 7. Number, dose and duration of therapy with recombinant erythropoietin (descriptive) 8. Inflammatory parameters on iron metabolism and correlation with above mentioned end points (descriptive and explorative) 9. Impact of nutritinal status on iron deficiency anemia and therapy success (explorative) 10. Tolerance and toxicity (descriptive) 11. Dropout due to toxicity or patients will (descriptive) 12. Overall survival;Timepoint(s) of evaluation of this end point: 12 weeks after baseline for all secondary endpoints except overall survival. Overall survival: 2 years after baseline.	—

Measure

Time frame

Secondary end point(s): 1. Fatigue via EORTC-QLQ-FA13 (descriptive) 2. Quality of life via EORTC-QLQ-C30 (descriptive) 3. Manual force via Hydraulic Hand Dynamometer (descriptive) 4. Number of allogenic blood transfusions (total and number of patients); (descriptive) 5. Time to normalization of hemoglobin (descriptive) 6. Genesis of iron deficiency anemia: iron deficiency anemia in chronic diseased patients vs. absolute iron deficiency without chronic disease (explorative) 7. Number, dose and duration of therapy with recombinant erythropoietin (descriptive) 8. Inflammatory parameters on iron metabolism and correlation with above mentioned end points (descriptive and explorative) 9. Impact of nutritinal status on iron deficiency anemia and therapy success (explorative) 10. Tolerance and toxicity (descriptive) 11. Dropout due to toxicity or patients will (descriptive) 12. Overall survival;Timepoint(s) of evaluation of this end point: 12 weeks after baseline for all secondary endpoints except overall survival. Overall survival: 2 years after baseline.

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Countries

Germany

Contacts

Public ContactIKF

IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest gGmbH

albatran.salah@khnw.de+496976014420

Outcome results

None listed

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