| Source of record | UK Trials |
| ISRCTN | ISRCTN54672574 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | NAG9007 |
| Public title | A randomised, parallel group study on efficacy and tolerability of Escherichia coli rHu granulocyte-macrophage colony-stimulating factor (GM-CSF) given subcutaneously for seven days after chemotherapy in paediatric malignancy |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Chemotherapy in paediatric malignancy |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Newly diagnosed soft tissue sarcoma, Ewing's sarcoma, medulloblastoma, osteosarcoma or Non-Hodgkin's Lymphoma
2. Age range one to 15 years
3. No history of anaphylaxis
4. No severe lung, heart or kidney impairment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1993 |
| Anticipated end date | 30/11/1993 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. GM-CSF regimen: myelosuppressive chemotherapy followed by Escherichia coli rHu GM-CSF given subcutaneously for seven days
2. Control regimen: myelosuppressive chemotherapy |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | United Kingdom Children's Cancer Study Group (UK) |
| Sponsor name | United Kingdom Children's Cancer Study Group (UK) |
| Sponsor details | University of Leicester
3rd floor
Hearts of Oak House
9 Princess Road West
Leicester
United Kingdom
LE1 6HT |
| Sponsor website | http://www.ukccsg.org |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN54672574 |
| Date last extracted from ISRCTN register | 17/04/2008 |
