Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study 11
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
Treatment
Patient information sheet
Condition
Lung (non-small cell) cancer
Intervention
1. GC Arm: 3-weekly regimen. Gemcitabine 1200 mg/m2 IV (Day 1 and 8) Carboplatin (AUC 5). Dose calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day 1)
2. MIC 3-Weekly regimen: Mitomycin 6 mg/m2 IV (Day 1) Ifosfamide 3 g/m2 IV (Day 1) Cisplatin 50 mg/m2 IV (Day 1)
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
31/08/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically or cytologically proven non-small cell carcinoma of the lung
2. Stage IIIb or IV disease
3. Measurable or evaluable disease
4. Adequate renal function (Ethylene diamine tetraacetic acid [EDTA] Clearance >60 ml/min)
5. Age 18 or over
6. Adequate contraception in females of child-bearing potential
7. Written informed consent
8. No prior radiotherapy or chemotherapy
9. Not less than 8 weeks life expectancy
10. No history of prior malignancy (except non-melanomatous skin tumour or has been without evidence of disease for 3 years or more)
11. White cell count >3000/ml Platelet count >100,000/ml Haemaglobin >10.0 g.dL
12. No symptomatic brain metastases
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
01/01/1995
Recruitment end date
31/08/2001
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
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
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15625369
Publication citations
-
Results
Rudd RM, Gower NH, Spiro SG, Eisen TG, Harper PG, Littler JA, Hatton M, Johnson PW, Martin WM, Rankin EM, James LE, Gregory WM, Qian W, Lee SM, Gemcitabine plus carboplatin versus mitomycin, ifosfamide, and cisplatin in patients with stage IIIB or IV non-small-cell lung cancer: a phase III randomized study of the London Lung Cancer Group., J. Clin. Oncol., 2005, 23, 1, 142-153, doi: 10.1200/JCO.2005.03.037.