Lung Cancer Clinical Trial
Official title:
Single-Agent Versus Combination Chemotherapy in Advanced NSCLC: A CALGB Randomized Trial of Efficacy, Quality of Life, and Cost-Effectiveness
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or
without carboplatin in treating patients who have recurrent, stage IIIB, or stage IV
non-small cell lung cancer.
OBJECTIVES: I. Compare the overall survival of patients with non-small cell lung cancer
treated with paclitaxel alone or in combination with carboplatin. II. Compare the quality of
life of these patients treated with these chemotherapy regimens. III. Compare the response
rates and the toxic effects of the two regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to stage of disease
(stage IIIB vs stage IV vs recurrent or progressive after surgery and/or radiotherapy),
performance status (0-1 vs 2), and age (under 70 vs 70 and over). Patients are randomized to
one of two treatment arms. Arm I receives paclitaxel IV over 3 hours on day 1 of each
course. Arm II receives paclitaxel as in Arm I, followed by carboplatin IV over 1 hour.
Treatment is repeated every 21 days for 6 courses in the absence of tumor progression or
unacceptable toxicity. Quality of life assessments are conducted before treatment and at 2,
6, 9, and 12 months. Patients are followed every 3 months for 2 years, then every 6 months
until disease progression or death.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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