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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Pulmonary Neoplasms

Intervention / Treatment
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* Drug: Preoperative docetaxel-cisplatin combination chemotherapy
* Drug: Preoperative docetaxel monotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Preoperative docetaxel-cisplatin combination chemotherapy | Drug: Preoperative docetaxel-cisplatin combination chemotherapy<br>* Preoperative docetaxel-cisplatin combination chemotherapy<br>|
| Active Comparator: 2<br>Preoperative docetaxel monotherapy | Drug: Preoperative docetaxel monotherapy<br>* Preoperative docetaxel monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival rate at 1 year |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary neoplasm, preoperative chemotherapy, cisplatin, docetaxel, randomized trial, clinical stage IB or II nonsmall cell lung cancer