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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Cisplatin; Docetaxel

Criteria

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