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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised 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 objectivesNot provided at time of registration.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSmall-Cell Lung Cancer (SCLC)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Etopsimide, cyclophosphamide, doxorubicin and vincristine
Primary outcome measureNot provided at time of registration.
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/08/2002
Completion date01/08/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration.
Total final enrolment339
Key inclusion criteria1. 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 criteriaNot provided at time of registration.
Date of first enrolment01/08/2002
Date of final enrolment01/08/2003

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.