Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LU309
Study information
Scientific title
Oral chemotherapy versus intravenous chemotherapy in limited or extensive small cell lung cancer: a randomised controlled trial
Acronym
Study hypothesis
Not provided at time of registration
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung (small cell)
Intervention
1. Oral Regimen: Oral etoposide and cyclophosphamide given over 5 days every 3 weeks.
2. Intravenous Regimen: Intravenous combination of three or more drugs routinely used in the centre with the usual dose reduction. A standard alternative is adriamycin, cyclophosphamide and vincristine (VAC) repeated every 3 weeks.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Histologically or cytologically proven small cell lung cancer
2. No previous or concurrent malignancy
3. Fit to receive chemotherapy
4. No prior chemotherapy or radiotherapy
5. No biochemical or haematological abnormalities which would preclude chemotherapy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
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
Basic results (scientific)
Publication list
1. 1996 interim results in http://www.ncbi.nlm.nih.gov/pubmed/8774567
Publication citations
-
Interim results
Girling DJ, Comparison of oral etoposide and standard intravenous multidrug chemotherapy for small-cell lung cancer: a stopped multicentre randomised trial. Medical Research Council Lung Cancer Working Party., Lancet, 1996, 348, 9027, 563-566.