Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)

UMIN ID: UMIN000001779

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small Cell Lung Cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 125
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After CDDP 80mg/m2 + Docetaxel 60mg/m2, day 1 q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, more than 6 months, maximum 1 year

Outcome(s)

• Primary Outcome: treatment completion proportion
• Secondary Outcome: overall survival, relapse free survival, pattern of recurrence, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) not recovered from surgical complications 2) active infection such as bacterial infection 3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infraction within 6 months 5) patinets with uncontroled complications 6) grade 2 or greater peripheral neuropathy 7) active concomitant malignancy 8) pregnant or lactating woman 9) past history of allergic reactions to polysorbate 80 10) concomitant therapy with flucytocine 11) pneumonectomy 12) other conditions not suitable for this study

Related Information

• Primary Sponsor: Thoracic Oncology Research Group (TORG)
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO.,LTD.