Finding studies
Finding studies
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Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * To determine the potential overall survival benefit of adjuvant chemotherapy in patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy compared to those randomized to the present standard of care (observation). * To collect and process high-quality fresh frozen lung cancer tumor tissue for gene expression array generation from multiple institutions. Secondary * To evaluate selected genomic-based lung cancer prognostic models using data from the patients randomized to observation after resection. * To characterize the rate of chemotherapy toxicity for the different chemotherapy treatment regimens. * To assess quality of life (QOL) in early stage patients periodically after resection for NSCLC. * To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as compared to patients in the observation arm. OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms within 12 weeks after surgery. All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection). * Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1. * Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1. * Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1. * Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1. * Arm II: Patients receive standard care (observation). Tissue obtained at surgery is examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each patient and correlated with survival and response. After completion of study treatment, patients are followed every 6 months for 5 years and then once a year for 7 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
