A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
- Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin
vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small
cell lung cancer.
- Compare symptom control and quality of life of patients treated with these regimens.
- Compare response in patients treated with these regimens.
- Compare the dose intensity of these regimens in these patients.
- Compare the ratio of courses of treatment given as in-patient vs out-patient in these
- Compare the intensity and number and duration of toxic episodes in patients treated
with these regimens.
- Compare cost and cost-effectiveness of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO
performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center.
Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV
over 1 hour on day 1.
- Arm II: Patients receive gemcitabine as in arm I and cisplatin (at a lower dose than in
arm I) IV over 1 hour on day 1.
- Arm III: Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day
In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2
courses. Patients with responding disease or stable disease with symptom improvement receive
2 additional courses of therapy in the absence of disease progression or unacceptable
toxicity. Patients with disease progression or stable disease without symptom improvement
are removed from the study.
Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study
treatment, and then monthly for 6 months.
After completion of study treatment, patients are followed monthly for 6 months and then
periodically thereafter for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for
this study within 6 years.
Allocation: Randomized, Primary Purpose: Treatment
Length of survival
Institute of Clinical Research - Birmingham