Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LU16
Study information
Scientific title
Randomised controlled clinical trial of oral etoposide versus intravenous multi-drug chemotherapy in the palliative treatment of patients with Small-Cell Lung Cancer (SCLC) and a poor prognosis
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Small-Cell Lung Cancer (SCLC)
Intervention
1. Oral Etoposide Regimen (E): Four courses of oral etopsimide twice daily for ten days at three week intervals (i.e. ten days of chemotherapy in each three week period).
2. Intravenous Multi-Drug
Chemotherapy Regimen (EV or CAV): Clinicians chose to use one of two multi-drug chemotherapy regimens: EV: Intravenous etoposide and vincristine four courses given at three week intervals, each course given over three days according to the protocol.
CAV: Intravenous cyclophosphamide, doxorubicin and vincristine four courses given at three week intervals, each course given on one day.
All treatments should start as soon as possible after randomisation.
Intervention type
Drug
Phase
Not Specified
Drug names
Etopsimide, cyclophosphamide, doxorubicin and vincristine
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/08/2002
Overall trial end date
01/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Microscopically proven SCLC
2. Limited or extensive disease
3. World Health Organisation (WHO) performance status grade two, three or four
4. No previous chemotherapy, radiotherapy, or surgery for small-cell lung cancer
5. No other previous or concomitant malignant disease, except basal cell carcinoma or in situ carcinoma of the cervix
6. No other serious condition contraindicating treatment with cytotoxic chemotherapy. Patients with evidence of liver cell damage are eligible
7. Renal function normal: plasma creatinine or urea concentration within normal limits
8. Plasma Billirubin less than 35 µmol/l
9. Any age, either sex
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration.
Total final enrolment
339
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/08/2002
Recruitment end date
01/08/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
unknown
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
Basic results (scientific)
Publication list
1996 results in: https://www.ncbi.nlm.nih.gov/pubmed/8774567 (added 15/11/2019)