Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403)

UMIN ID: C000000205

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage IIIB or Stage IV Non-Small Cell Lung Cancer
• Date of first enrollment: 2004/03/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention arm: Cisplatin (60mg/m2, day1), Docetaxel (60mg/m2, day 1), Irinotecan (60mg/m2, day 2) combination chemotherapy
Control arm: Cisplatin (80mg/m2, day1), Docetaxel (60mg/m2, day 1) combination chemotherapy

Outcome(s)

• Primary Outcome: Overall survival Quality of life
• Secondary Outcome: Best overall response Duration of overall response Time to progression Adverse event

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Symptomatic brain metastasis 2. Active concomittant malignancy, history of previous chemotherapy or thoracic radiation therapy for malignancy 3. Clinically significant allergic history 4. Pregnant or lactating women 5. Severe comrbidities 1) Active interstial pneumonia 2) Unstable angina pectoris, or recent history of myocardial infarction 3) Uncntrolled diabetes mellitus 4) Sever active infection 5) Pleural effusion or ascites which require treatment 6) Clinically significant pericardial effusion 7) Other clinical condition which is considered as inappropriate for this study

Related Information

• Primary Sponsor: Okayama Lung Cancer Study Group (OLCSG)
• Source(s) of Monetary Support: N/A