Status:
COMPLETED
Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Pulmonary Neoplasms
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
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 f...
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, platinu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00132639
Start Date
October 1 2002
End Date
November 1 2008
Last Update
September 22 2016
Active Locations (1)
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1
National Cancer Center
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045