Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TR9SCLC
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lung (small cell)
Intervention
1. Regimen A: Chemotherapy, oral etoposide repeated every 3 weeks for six courses.
2. Regimen B: Multi-drug chemotherapy, CAV (cyclophosphamide, adriamycin, vincristine) alternating every 3 weeks with PE (etoposide, cisplatin). A total of six courses, three with each drug combination.
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
01/01/1997
Overall trial end date
31/12/2000
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Histologically or cytologically proven SCLC
2. Patients with extensive disease and poor prognosis, i.e., Eastern Cooperative Oncology Group (ECOG) performance 2 or 3 or alkaline phosphatase >1.5 upper limit normal range
3. Patients 75 years and over, whatever stage of disease, deemed fit for randomisation
4. No previous malignancy, except non-melanomatous skin cancer in the preceding 3 years
5. No medical contraindications to treatment
6. Adequate renal function
Participant type
Patient
Age group
Senior
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
01/01/1997
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
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
1996 results in: http://www.ncbi.nlm.nih.gov/pubmed/8774567
Publication citations
-
Results
Girling DJ, Comparison of oral etoposide and standard intravenous multidrug chemotherapy for small-cell lung cancer: a stopped multicentre randomised trial. Medical Research Council Lung Cancer Working Party., Lancet, 1996, 348, 9027, 563-566.