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
| ISRCTN | ISRCTN89698860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89698860 |
| Secondary identifying numbers | BR0101 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 08/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 | Breast |
| Intervention | 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. |
| 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 | 03/10/2001 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 400 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 03/10/2001 |
| Date of final enrolment | 31/12/2006 |
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
Anglo Celtic Cooperative Oncology Group (UK)
Research organisation
Research organisation
SCTN Central Office
Information & Statistics Division
Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom
| Phone | +44 (0)131 551 8363 |
|---|---|
| joanna.dunlop@isd.csa.scot.nhs.uk | |
| Website | http://www.amgen.com |
Funders
Funder type
Industry
Anglo Celtic Cooperative Oncology Group, Amgen (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
