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 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 trial start date
01/04/1997
Overall trial end date
31/03/1999
Reason abandoned (if study stopped)
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
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
Basic results (scientific)
Publication list
1996 results in: https://www.ncbi.nlm.nih.gov/pubmed/8562352 (added 15/11/2019)