A phase II study of CBDCA and TS-1 in patients with advanced non-small cell lung cancer

UMIN ID: UMIN000001746

Registered date:03/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced non-small cell lung cancer
• Date of first enrollment: 2007/06/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Carboplatin and TS-1 chemotherapy

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: To assess toxicity, overall survival and progression-free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Pulmonary fibrosis detectable on chest X-ray films 2)Massive pleural effusion, ascites and pericardial effusion required drainage 3)Concomitant malignancy 4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome 5)Symptomatic brain metastasis 6)Pregnant or milk-feeding female. Intention to be pregnant in the future 7)With severe allergy 8)Other clinical difficulties to this study

Related Information

• Primary Sponsor: Gunma University Hospital
• Source(s) of Monetary Support: none