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 (NCT) NCT00002822
Protocol serial number LU21
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
Submission date
06/04/2000
Registration date
06/04/2000
Last edited
02/09/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/lu21-chemotherapy-for-small-cell-lung-cancer

Contact information

Dr Danielle Andrews
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleRandomised 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 objectivesTo 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) studiedCancer
Intervention1. One group receives intensive regimen of VICE without dose reduction but with dose delay permitted
2. The other group receives standard practice chemotherapy
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)ifosfamide, carboplatin and etoposide with mid-cycle vincristine (VICE)
Primary outcome measure(s)

Survival time, quality of life

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/12/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration400
Total final enrolment402
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/12/1995
Date of final enrolment01/12/2001

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

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

Editorial Notes

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

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