Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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.

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes