Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study 10
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) cancer
Intervention
1. GC Arm: 3-weekly regimen (6 cycles) Gemcitabine 1200 mg/m(2) IV (Day 1 and 8) Carboplatin (AUC 5) Dose in mg calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day1)
2. PE Arm: 3-weekly regime (6 cycles): Cisplatin 60 mg/m2 IV Day 1 Etoposide 120 mg/m2 IV (Day 1) and 100 mg bd po (days 2 and 3)
Intervention type
Drug
Phase
Phase III
Drug names
Cancer drugs
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1996
Overall trial end date
31/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically or cytologically proven small cell anaplastic carcinoma of the lung
2. Extensive stage disease or limited stage but locally advanced or limited stage with poor prognostic factors
3. Measurable or evaluable disease
4. Adequate renal function for chemotherapy
5. Age 18 years or above
6. Adequate contraception for women of child bearing potential
7. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1996
Recruitment end date
31/10/2001
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
NCRI CSG and London Lung Cancer Group (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
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11510029
Publication citations
-
Results
Steele JP, Gemcitabine/carboplatin versus cisplatin/etoposide for patients with poor-prognosis small cell lung cancer: a phase III randomized trial with quality-of-life evaluation., Semin. Oncol., 2001, 28, 3 Suppl 10, 15-18.