A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503

UMIN ID: UMIN000001244

Registered date:11/07/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Non-Small-Cell Lung Cancer
• Date of first enrollment: 2006/04/01
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A:paclitaxel 200mg/m2 + carboplatin AUC6, day1 q3-4w, 3 courses
B: docetaxel 60mg/m2 + cisplatin 80mg/m2, day1 q3-4w, 3 courses

Outcome(s)

• Primary Outcome: 2-year relapse free survival
• Secondary Outcome: Overal survival Incidence of an adverse event QOL(FACT-T) Feasibility

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) not recovered from surgical complications 2) active infection such as bacterial infection 3) patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infarction within 6 months 5) patients with uncontrolled complications 6) grade 2 or greater peripheral neuropathy 7) active concomitant malignancy 8) pregnant or lactating women 9) past history of allergic reactions to polysorbate 80 10) pneumonectomy 11) bronchoplasty 12) other conditions not suitable for this study

Related Information

• Primary Sponsor: Thoracic Oncology Research Group (TORG)
• Source(s) of Monetary Support: Thoracic Oncology Research Group (TORG)