Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
17/11/2015
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

LU12

Study information

Scientific title

Medical Research Council Sixth Small Cell Study: A Controlled Clinical Trial of Two Policies of Chemotherapy for Poor Prognosis Patients with Small-Cell Lung Cancer (SCLC)

Acronym

Study hypothesis

(Added 05/08/09) What is the comparison in poor prognosis patients with SCLC with the standard chemotherapy used in 3 previous MRC studies, etoposide, cyclophosphamide, methotrexate and vincristine (ECMV) and 3 courses of etoposide & vincristine (EV), with respect to palliation of symptoms, performance status, toxicity, response to treatment and survival?

As of 05/08/09 this record has been extensively updated. All updates can be found under the relavent field with the above update date. Please also note that the trial start and end dates have been changed from 19/08/2002 and 19/08/2003 respectively, as these dates were automatically generated by the system at time of registration.

Ethics approval

No ethics information required at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lung (small cell) cancer

Intervention

1. ECMV Regimen: Three courses three weeks apart of Etoposide, Cyclophosphamide, Methotrexate and Vincristine.
2. EV Regimen: Three courses three weeks apart of Etoposide and Vincristine. Thoracic radiotherapy and prophylactic cranial irradiation should not be given as a routine. If a patient needs radiotherapy to metastatic sites or to the primary site to control symptoms, the details should be decided by the radiotherapist and recorded as appropriate.

Intervention type

Drug

Phase

Not Specified

Drug names

Etoposide, cylophosphamide, mathotrexate, vincristine

Primary outcome measures

Added 05/08/09:
1. Palliation of symptoms
2. Toxicity
3. Performance status
4. Quality of life
5. Response rate

Initial outcome measures not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1997

Overall trial end date

31/03/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primarily untreated microscopically confirmed SCLC
2. Age <80
3. Limited disease: poor performance status (World Health Organisation [WHO] grade 3 or 4). Extensive disease: performance status any grade
4. Renal function normal
5. Plasma Billirubin not greater than twice normal levels

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Previous anticancer treatment for current SCLC
2. Presence of other malignant disease (except previous basal cell carcinoma or in situ carcinoma of the cervix)
3. Presence of other serious condition contraindicating the study regimens

Recruitment start date

01/04/1997

Recruitment end date

31/03/1999

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 Reseach Council (MRC) (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

17/11/2015: No publications found in PubMed.