A Phase III Randomized, Multicenter Study Comparing Irinotevan and Cisplatin (IP) with Amrubicin and Cisplatin (AP) for the Treatment of Extensive-Stage Small-Cell Lung Cancer: (JCOG0509)

UMIN ID: UMIN000000720

Registered date:22/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: extensive-disease small cell lung cancer
• Date of first enrollment: 2007/05/01
• Target sample size: 282
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A : Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 60-120 minutes on day 1. Courses repeat every 4 weeks.
B : Patients receive Amrubicin IV in 5 minutes on days 1-3 and cisplatin IV over 60-120 minutes on day 1. Courses repeat every 3 weeks.

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: progression-free survival, response rate, diarrhea(Grade3/4), adverse events, QOL

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) active concomitant malignancy 2) severe complications related malignancy (Superior vena cava syndrome, pleural effusion that required drainage, pericarditis carcinomatous, symptomatic brain metastasis) 3) active infection 4) watery diarrhea 5) intestinal obstruction or paralysis 6) interstitial pneumonia/active lung fibrosis on chest x-ray 7) non-steroidal anti-inflammatory drug or glucocorticoid use for >50 days 8) uncontrolled diabetes mellitus, 9) uncontrolled heart disease or a history of myocardial infarction within the previous 6 months 10) psychological disease deemed unacceptable for inclusion to the study 11) pregnant or lactating women 12) active gastric and/or duodenal ulcer

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare