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

ISRCTN	ISRCTN71172156
DOI	https://doi.org/10.1186/ISRCTN71172156
Secondary identifying numbers	LU16

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 15/11/2019

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

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Etopsimide, cyclophosphamide, doxorubicin and vincristine
Primary outcome measure	Not provided at time of registration.
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/08/2002
Completion date	01/08/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration.
Total final enrolment	339
Key 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
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/08/2002
Date of final enrolment	01/08/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	31/08/1996	15/11/2019	Yes	No

Editorial Notes

15/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.