Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof David Ferry
ORCID ID
Contact details
Eli Lilly and Company
Bridgewater
NJ
-
United States of America
-
ferry_david@lilly.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00112710
Protocol/serial number
LU 3005
Study information
Scientific title
A British Thoracic Oncology Group phase III trial of Gemcitabine plus Cisplatin at 80 mg/m^2 versus Gemcitabine plus Cisplatin at 50 mg/m^2 versus Gemcitabine plus Carboplatin area under the concentration-time curve (AUC) 6 in stage IIIB/IV non-small cell lung cancer (NSCLC)
Acronym
BTOG2
Study hypothesis
To establish the optimal cisplatin dose and whether carboplatin can be effectively substituted for the cisplatin at this dose
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-small cell lung cancer
Intervention
Chemotherapy - Gemcitabine plus Cisplatin at 80 mg/m^2 versus Gemcitabine plus Cisplatin at 50 mg/m^2 versus Gemcitabine plus Carboplatin AUC 6
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine, cisplatin, carboplatin
Primary outcome measure
Length of survival
Secondary outcome measures
1. Symptom control and quality of life
2. Response to treatment
3. Dose intensity of chemotherapy
4. Ratio of cycles given as in-patient versus out-patient
5. Intensity, number and duration of toxic episodes (grade two to four)
6. Costs
7. Proteomic and genomic
Overall trial start date
01/04/2005
Overall trial end date
01/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically or cytologically confirmed NSCLC (excluding mixed SCLC/NSCLC)
2. Radiologically verified stage IIIB (unsuitable for radical radiotherapy) or stage IV disease
3. Presence of one or more clinically or radiological measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
4. World Health Organisation (WHO) Performance status zero, one or two
5. Aged over 18 years
6. Life expectancy more than 12 weeks
7. Adequate haematological function and hepatobiliary function
8. Creatinine clearance: 60 ml/min or 70 ml/min (51Cr-EDTA)
9. Able to participate in the quality of life assessment
10. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1350
Total final enrolment
1363
Participant exclusion criteria
1. Prior chemotherapy or radiotherapy (prior surgical resection is allowed)
2. Evidence of severe or uncontrolled systemic diseases
3. Evidence of significant clinical disorder or laboratory finding
4. Concomitant or previous malignancy likely to interfere with protocol treatment or comparisons
5. Pre-existing neuropathy grade more than two
6. Clinically apparent metastatic disease to brain
7. Unresolved toxicity or incomplete recovery from previous surgery
8. Psychiatric disorder making informed consent impossible or preventing completion of treatment or follow-up
9. Previous investigational agent in the last 12 weeks
10. Male and female patients (of childbearing age) not using adequate contraception
11. Female patients who are pregnant or breast-feeding
Recruitment start date
01/04/2005
Recruitment end date
01/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Wolverhampton Hospitals NHS Trust
Wolverhampton
WV10 0QP
United Kingdom
Sponsor information
Organisation
University of Birmingham
Sponsor details
Research Support Group
Aston Webb Building
Room 117
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
researchgovernance@contacts.bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
2011 results in http://thorax.bmj.com/content/66/Suppl_4/A41.1
2017 results in https://pubmed.ncbi.nlm.nih.gov/28780466/ (added 12/10/2020)