Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
04/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Danielle Andrews

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16293867

Publication citations

  1. 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.

Additional files

Editorial Notes