Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Pulmonary Neoplasms
- Interventions
- Drug: Preoperative docetaxel-cisplatin combination chemotherapy
- Registration Number
- NCT00132639
- Lead Sponsor
- Haruhiko Fukuda
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Preoperative docetaxel monotherapy Preoperative docetaxel monotherapy 1 Preoperative docetaxel-cisplatin combination chemotherapy Preoperative docetaxel-cisplatin combination chemotherapy
- Primary Outcome Measures
Name Time Method disease-free survival rate at 1 year during the study conduct
- Secondary Outcome Measures
Name Time Method overall survival during the study conduct disease-free survival during the study conduct treatment compliance during the study conduct response rate to chemotherapy during the study conduct pathologic complete response (CR) rate during the study conduct complete resection rate during the study conduct post-surgical morbidity/mortality during the study conduct
Trial Locations
- Locations (1)
National Cancer Center
🇯🇵Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan