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ISRCTN
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ISRCTN89698860
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ClinicalTrials.gov identifier
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Public title
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Prospective randomised comparison of granulocyte colony-stimulating factor (G-CSF) (filgrastim) secondary prophylaxis versus conservative management of chemotherapy-induced neutropenia to maintain dose intensity in chemotherapy for breast cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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BR0101
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast
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Participants - inclusion criteria
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1. 18 years or older
2. Histologically confirmed invasive breast cancer
3. No concomitant malignancy
4. No prior chemotherapy (apart from the current regimen)
5. Previous neutropenic event on iv chemotherapy and considered of suitable risk and fitness to continue chemotherapy
6. Written informed consent
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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03/10/2001
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Standard iv chemotherapy regimens as per local guidelines.
Patients entered into TACT or TANGO protocols, or other protocols of licensed chemotherapies which do not exclude G-CSF usage will be eligible for this protocol.
Patients in the SECRAB trial will also be eligible. G-CSF to be dosed subcutaneously at 5 micrograms/kg from day 3 post chemotherapy until day 9 (7 days). For the purposes of dosing, the last day of chemotherapy administration will be day 1. In the case of Day 1/Day 8 regimens, G-CSF shall be dosed starting on day 10 for 7 days.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Anglo Celtic Cooperative Oncology Group, Amgen (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Anglo Celtic Cooperative Oncology Group (UK)
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Address
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SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
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City/town
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Edinburgh
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Zip/Postcode
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EH5 3SQ
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Country
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United Kingdom
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Tel
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+44 (0)131 551 8363
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Fax
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+44 (0)131 552 4085
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Email
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joanna.dunlop@isd.csa.scot.nhs.uk
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Sponsor website:
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http://www.amgen.com
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Date applied
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19/08/2002
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Last edited
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14/05/2008
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Date ISRCTN assigned
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19/08/2002
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