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)

ISRCTN	ISRCTN36984145
DOI	https://doi.org/10.1186/ISRCTN36984145
Secondary identifying numbers	LU12

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)	Hospital
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	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)
Study objectives	(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(s)	No ethics information required at time of registration.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Etoposide, cylophosphamide, mathotrexate, vincristine
Primary outcome measure	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 study start date	01/04/1997
Completion date	31/03/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key 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
Date of first enrolment	01/04/1997
Date of final enrolment	31/03/1999

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 Reseach Council (MRC) (UK)

No information available

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	01/02/1996	15/11/2019	Yes	No

Editorial Notes

15/11/2019: Publication reference added.
17/11/2015: No publications found in PubMed.