Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002822
Protocol/serial number
LU21
Study information
Scientific title
Acronym
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer
Intervention
1. One group receives intensive regimen of VICE without dose reduction but with dose delay permitted
2. The other group receives standard practice chemotherapy
Intervention type
Drug
Phase
Not Specified
Drug names
ifosfamide, carboplatin and etoposide with mid-cycle vincristine (VICE)
Primary outcome measure
Survival time, quality of life
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1995
Overall trial end date
01/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/1995
Recruitment end date
01/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16293867
Publication citations
-
Results
Thatcher N, Qian W, Clark PI, Hopwood P, Sambrook RJ, Owens R, Stephens RJ, Girling DJ, Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial., J. Clin. Oncol., 2005, 23, 33, 8371-8379, doi: 10.1200/JCO.2004.00.9969.