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
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