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.

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