Condition category
Haematological Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giuseppe Giaccone

ORCID ID

Contact details

VU Medical Centre
Principal Investigator Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4444321
g.giaccone@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR250

Study information

Scientific title

Acronym

Study hypothesis

To determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumours.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Anaemia

Intervention

Epoetin alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.

Intervention type

Supplement

Phase

Not Specified

Drug names

Iron supplementation, Epoetine alfa, iron (III)-hydroxyde-sucrose, ferrofumarate

Primary outcome measures

Increase in Hb

Secondary outcome measures

1. Number of required blood transfusions
2. Total dose of administered recombinant human erythropoietin alpha (rHuEPO)

Overall trial start date

01/02/2001

Overall trial end date

30/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of a solid malignancy and planned to receive further non-platinum containing chemotherapy for at least 12 weeks
2. Haemoglobin (Hb) less than or equal to 7.5 mmol/L at any time during chemotherapy
3. Transferrin saturation (TSAT) less than 20% and/or serum ferritin less than 100 ng/ml
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. Life expectancy at least 3 months
6. Aged 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant exclusion criteria

1. Mean corpuscular volume (MCV) less than 80 fL and mean corpuscular haemoglobin count (MCHC) less than 195 mmol/L
2. MCV greater than 100 fL
3. Clinically significant chronic blood loss
4. Clinically significant disease/dysfunction of the pulmonary, cardiovascular, 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

Recruitment start date

01/02/2001

Recruitment end date

30/07/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

http://www.vumc.nl

Funders

Funder type

University/education

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes