A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)
- Compare the rates of overnight hospitalization due to toxicity (e.g., blood
transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of
patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs
gemcitabine and carboplatin.
- Compare the need for hospitalization for chemotherapy administration in patients
treated with these regimens.
- Compare the tumor response rate of patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the relief of tumor-related symptoms in patients treated with these regimens.
- Compare the effect on Karnofsky performance status in patients treated with these
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
(IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours
on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin
IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 2 months for 6 months and then every 3-4 months thereafter.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Rate of hospitalization due to toxicity
Nick Thatcher, PhD, FRCP
Christie Hospital NHS Foundation Trust
United States: Federal Government