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Randomized study on hemoglobin response in iron-deficient anemic patients with solid maglignancies receiving epoetin alfa (rHuEPO) in combination with either oral or parental iron supplementation during treatment with non-platinum containing chemotherapy.


- candidate number1431
- NTR NumberNTR250
- ISRCTNISRCTN61345286
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsN/A 
- Public TitleRandomized study on hemoglobin response in iron-deficient anemic patients with solid maglignancies receiving epoetin alfa (rHuEPO) in combination with either oral or parental iron supplementation during treatment with non-platinum containing chemotherapy.
- Scientific TitleRandomized study on hemoglobin response in iron-deficient anemic patients with solid maglignancies receiving epoetin alfa (rHuEPO) in combination with either oral or parental iron supplementation during treatment with non-platinum containing chemotherapy.
- ACRONYMN/A
- hypothesisTo determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumors.
- Healt Condition(s) or Problem(s) studiedTumour, Iron deficiency , Anemia
- Inclusion criteria1. Confirmed diagnosis of a solid malignancy and planned to receive further non-platinum containing chemotherapy for at least 12 weeks;
2. Hb 7.5 mmol/L at any time during chemotherapy;
3. TSAT <20% and/or serum ferritin < 100 ng/ml;
4. ECOG Performance Status of 0, 1 or 2;
5. Life expectancy at least 3 months;
6. Age between 18-75 years;
7. Sex: male or female. Female subjects must be either postmenopausal (for at least for 1 year), sterilised or, if of childbearing potential, be practising an acceptable method of birth control;
8. Subjects must have read and signed the informed consent form.
- Exclusion criteria1. MCV <80fL and MCHC <19.5 mmol/L;
2. MCV > 100fL;
3. Clinically significant chronic blood loss;
4. Clinically significant disease/dysfunction of the pulmonary, cardio-vascular, endocrine, neurological, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy. This dysfunction is only an exclusion criteria if it causes an expected early withdrawal from the study;
5. Uncontrolled hypertension, defined as a diastolic blood pressure greater than 100 mmHg, despite antihypertensive medication;
6. History of seizures;
7. Known hypersensitivity to Epoetin alfa or one of its components;
8. Administration of intravenous iron preparations within 3 months before study entry;
9. Participation in any other clinical trial involving unlicensed medication or procedures;
10. Androgen therapy within two months of study entry.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2001
- planned closingdate30-jul-2003
- Target number of participants34
- InterventionsEpoetine alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.
- Primary outcomeIncrease in Hb.
- Secondary outcomeNumber of required blood transfusions, total dose of administered rHuEPO.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. Giuseppe Giaccone
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Giuseppe Giaccone
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD7-sep-2005 - 4-jun-2008


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