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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN98318971 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A double-blind, placebo controlled study to assess the effects of early intervention and/or treatment with epoetin alfa on anaemia in cancer patients receiving non-platinum containing chemotherapy
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Scientific title:
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Date of first enrolment:
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01/01/2003 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN98318971 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosis of non-myeloid malignancy, which requires non-platinum containing chemotherapy
2. Predicted chemotherapy of 12 to 24 weeks (three to six cycles) duration
3. Performance score zero to three
4. Life expectancy of more than six months
5. Aged over 18 years
6. Patients with acute leukaemia are excluded
7. No myeloablative chemotherapy
8. No uncontrolled hypertension
9. No evidence of untreated iron, folate or vitamin B12 deficiency
Exclusion criteria: Does not comply with the above inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anaemia
Haematological Disorders
Anaemia in chronic diseases classified elsewhere
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Intervention(s)
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Patients are randomised to one of two treatment arms:
1. Arm A: Patients receive 150 IU/Kg of Epoetin alpha
2. Arm B: Patients receive matching placebo
Epoetin alpha or placebo is given subcutaneously three times per week for the first four weeks (or the first on-study chemotherapy cycle, respectively). Haemaglobin level and/or reticulocyte count will then be used to determine whether the same dose (volume) or a doubled dose (volume) will be used for the remainder of the treatment.
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Primary Outcome(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Janssen-Cilag Ltd (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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