Randomized Phase II Study of the Induction Chemotherapy With Docetaxel Alone vs CDDP + Docetaxel for c-Stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials
are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In
each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet
is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different
in earlier stages. There have been no prospective randomized trials to choose an optimal
preoperative chemotherapy in early stage NSCLC.
Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in
clinical stage IB/II NSCLC.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease-free survival rate at 1 year
during the study conduct
Harubumi Kato, MD, PhD
Tokyo Medical University
Japan: Ministry of Health, Labor and Welfare