NCT00132639

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Haruhiko Fukuda · Academic / Other
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Neoplasms

Interventions

Type	Name	Description
DRUG	Preoperative docetaxel-cisplatin combination chemotherapy	Preoperative docetaxel-cisplatin combination chemotherapy
DRUG	Preoperative docetaxel monotherapy	Preoperative docetaxel monotherapy

Timeline

• Start date: 2002-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2005-08-22
• Last updated: 2016-09-22

Locations

1 site across 1 country: Japan