Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)

Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)

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)

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.

pulmonary neoplasm, preoperative chemotherapy, cisplatin, docetaxel, randomized trial, clinical stage IB or II nonsmall cell lung cancer

Inclusion Criteria: Newly diagnosed, pathologically documented NSCLC Clinical stages IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0) Ages: 15-74 years old ECOG performance status 0 or 1 Measurable disease Ample organ function Signed informed consent Exclusion Criteria: Invasion to the first rib or more superior chest wall Metastasis to, or involvement of, mediastinal node Active concomitant malignancy Unstable angina, recent myocardial infarction, or heart failure Uncontrolled diabetes or hypertension Pregnant or lactating women Other severe complications Systemic use of corticosteroids