|
ISRCTN
|
ISRCTN47862456
|
|
DOI
|
10.1186/ISRCTN47862456
|
|
ClinicalTrials.gov identifier
|
NCT00002822
|
|
EudraCT number
|
|
|
Public title
|
Randomised trial of ifosfamide, carboplatin and etoposide with mid-cycle vincristine (VICE) versus standard practice chemotherapy in patients with limited small cell lung cancer (SCLC) and good performance status
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
LU21
|
|
Study hypothesis
|
To compare an intensive regimen of VICE without dose reduction but with dose delay permitted versus standard practice chemotherapy in patients with limited stage SCLC and good performance status
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cancer
|
|
Participants - inclusion criteria
|
1. Previously untreated SCLC
2. Limited disease
3. WHO 0-2
4. Normal blood count
5. Glomerular Filtration Rate (GFR) greater than 65 ml/min
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/12/1995
|
|
Anticipated end date
|
01/12/2001
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
400
|
|
Interventions
|
1. One group receives intensive regimen of VICE without dose reduction but with dose delay permitted
2. The other group receives standard practice chemotherapy
|
|
Primary outcome measure(s)
|
Survival time, quality of life
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16293867
|
|
Contact name
|
Dr
Danielle
Andrews
|
|
Address
|
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
06/04/2000
|
|
Last edited
|
04/09/2009
|
|
Date ISRCTN assigned
|
06/04/2000
|