CarVin versus CarEto - A randomised phase II study of carboplatin and vinorelbine versus carboplatin and etoposide in good performance status small cell lung cancer patients presenting with adverse prognostic factors

ISRCTN ISRCTN44486227
DOI https://doi.org/10.1186/ISRCTN44486227
Secondary identifying numbers N0067120650
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
04/07/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ernie Marshall
Scientific

Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom

Phone +44 0151 334 1155
Email ernie.marshall@ccotrust.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesA randomised phase II study of carboplatin and vinorelbine versus carboplatin and etoposide in good performance status small cell lung cancer patients presenting with adverse prognostic factors.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer: Small cell lung cancer
Intervention1. Chemotherapy with carboplatin and vinorelbine
2. Chemotherapy with carboplatin and etoposide

Added July 2008: trial stopped because of poor recruitment
Intervention typeOther
Primary outcome measure1. Toxicity
2. Tumour response
Secondary outcome measuresNot provided at time of registration
Overall study start date08/04/2002
Completion date08/04/2006
Reason abandoned (if study stopped)Insufficient personel

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participantsTotal target recruitment = 80 patients
Key inclusion criteria1. Elderly patients >65 years with good prognosis and Eastern Cooperative Oncology Group (ECOG) p/s <2
2. Confirmed small cell lung cancer not considered eligible for aggressive multimodality therapy
Key exclusion criteriaNot provided at time of registration
Date of first enrolment08/04/2002
Date of final enrolment08/04/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clatterbridge Centre for Oncology
Wirral
CH63 4JY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Clatterbridge Centre for Oncology NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan