The purpose of this study is to evaluate the safety and efficacy of the preoperative docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Preoperative docetaxel-cisplatin combination chemotherapy
Preoperative docetaxel monotherapy
National Cancer Center
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan
disease-free survival rate at 1 year
Time frame: during the study conduct
overall survival
Time frame: during the study conduct
disease-free survival
Time frame: during the study conduct
treatment compliance
Time frame: during the study conduct
response rate to chemotherapy
Time frame: during the study conduct
pathologic complete response (CR) rate
Time frame: during the study conduct
complete resection rate
Time frame: during the study conduct
post-surgical morbidity/mortality
Time frame: during the study conduct
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