Contact information
Type
Scientific
Primary contact
Dr Ernie Marshall
ORCID ID
Contact details
Clatterbridge Centre for Oncology
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom
+44 0151 334 1155
ernie.marshall@ccotrust.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0067120650
Study information
Scientific title
Acronym
Study hypothesis
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.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cancer: Small cell lung cancer
Intervention
1. Chemotherapy with carboplatin and vinorelbine
2. Chemotherapy with carboplatin and etoposide
Added July 2008: trial stopped because of poor recruitment
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
1. Toxicity
2. Tumour response
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/04/2002
Overall trial end date
08/04/2006
Reason abandoned
Insufficient personel
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Total target recruitment = 80 patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
08/04/2002
Recruitment end date
08/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clatterbridge Centre for Oncology
Wirral
CH63 4JY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Clatterbridge Centre for Oncology NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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