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

ISRCTN	ISRCTN47862456
DOI	https://doi.org/10.1186/ISRCTN47862456
ClinicalTrials.gov number	NCT00002822
Secondary identifying numbers	LU21

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Danielle Andrews
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific 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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/12/1995
Completion date	01/12/2001

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	400
Total final enrolment	402
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/12/1995
Date of final enrolment	01/12/2001

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/11/2005		Yes	No
Plain English results			02/09/2022	No	Yes

02/09/2022: Cancer Research UK plain English results link and total final enrolment added.