Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.
1 other identifier
interventional
55
1 country
4
Brief Summary
The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2003
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedNovember 14, 2006
November 1, 2006
September 12, 2005
November 13, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biological response rate for each group.
Secondary Outcomes (4)
To determine tolerance for ferric saccharose (Venofer®)
To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
To determine percentage of hemoglobin rate's correction
To determine biological parameters's evolution
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Well-informed written consent, signed by the patient
- Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis
- Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9\<Hb\<12 g/dl; Women: 9\<Hb\<11 g/dl.
- Patients with life expectancy higher than three months
- Patient with general conditions compatible with the study's follow-up
You may not qualify if:
- Contra-indication for Venofer
- Anemia which can have curative treatment
- Bloody transfusion during the previous four weeks
- Documented or suspected medullary invasion
- Uncontrolled arterial hypertension
- Acute bacterial infection
- Transferrin saturation's coefficient
- Pregnancy
- Ferric salts oral treatment interrupted since less than one week
- Patient with bad french language's comprehension
- Patient with a major psychiatric pathology
- Patient under guardianship, trusteeship or justice safeguard
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre Hospitalier de Castres
Castres, France
Centre Hospitalier de Montauban
Montauban, France
Centre Hospitalier Joseph Ducuing
Toulouse, France
Institut Claudius Regaud
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland Dugat, Pr
Institut Claudius Regaud
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
November 1, 2003
Study Completion
April 1, 2006
Last Updated
November 14, 2006
Record last verified: 2006-11