Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/05/2014
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

TH/SMC

Study information

Scientific title

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

Condition

Lung (small cell)

Intervention

Good/moderate-prognosis patients: Patients receive chemotherapy with Ifosfamide, etoposide, mensa and vincristine (EIMV) for three courses. Patients with greater than 50% response are randomised to either:
1. Group A: No mandatory treatment, radiotherapy is optional.
2. Group B: Three further courses of EIMV chemotherapy plus optional radiotherapy.

Poor-prognosis patients: Chemotherapy is at the physicians discretion. If chemotherapy is chosen single agent etoposide or EIMV chemotherapy is recommended.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1994

Overall trial end date

01/04/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. Small cell lung cancer confirmed by histological or bronchial brush or aspirate cytology.
2. Aged <75 years
3. Normal renal and hepatic function
4. No evidence of brain metastases
5. No previous specific anti-cancer treatment for current disease
6. No other malignant disease, except basal cell carcinoma and in situ carcinoma of the cervix

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

01/01/1994

Recruitment end date

01/04/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Northern and Yorkshire Clinical Trials and Research Unit (UK)

Sponsor details

-
Leeds
-
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Northern & Yorkshire Clinical Trials & Research Unit (UK)

Alternative name(s)

Funding Body Type

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes