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
ISRCTN | ISRCTN98318971 |
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DOI | https://doi.org/10.1186/ISRCTN98318971 |
Secondary identifying numbers | GN308 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 19/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Anaemia |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2003 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Does not comply with the above inclusion criteria |
Date of first enrolment | 01/01/2003 |
Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Janssen-Cilag Ltd (UK)
Industry
Industry
Saunderton
High Wycombe
HP14 4HJ
United Kingdom
Phone | +44 (0)1494 567567 |
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Website | http://www.janssen-cilag.co.uk |
https://ror.org/03qwpn290 |
Funders
Funder type
Industry
Janssen-Cilag Ltd (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |