A Randomized Phase II Study Adjuvant Gemcitabine And Oxaliplatin Versus Gemcitabine and Cisplatin for Completely Resected Stage IB, II or IIIA Non-Small Cell Lung Cancer
This study is a randomized phase II study. Patients are randomized to 1 of 2 treatment arms:
patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or
gemcitabine-cisplatin. Chemotherapy should be started within 8 weeks after complete surgical
resection. Patients are followed every 3 months for 2 years, every 6 months for 3 years.
Gemcitabine-Oxaliplatin (GemOx) chemotherapy:
Gemcitabine (1,250 mg/m2)+Oxaliplatin (85 mg/m2) is given on day 1 and 15 q 4weeks. maximum
Gemcitabine-Cisplatin (GemCis) chemotherapy:
Gemcitabine (1,250 mg/m2) + Cisplatin (40 mg/m2) is given on day 1 and 15 q 4weeks. maximum
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare time to recurrence with these regimens
the first day of the treatment to date of the tumor recurrence
Jae-Ill Zo, M.D.
National Cancer Center, Korea
South Korea: Korea Food and Drug Administration (KFDA)