NIPH Clinical Trials Search

UMIN ID: UMIN000000720

Registered date:22/05/2007

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedextensive-disease small cell lung cancer
Date of first enrollment2007/05/01
Target sample size282
Countries of recruitmentJapan
Study typeInterventional
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.


Primary Outcomeoverall survival
Secondary Outcomeprogression-free survival, response rate, diarrhea(Grade3/4), adverse events, QOL

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Yoshikazu Kotani MD
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan Japan
Telephone 078-382-5846
Affiliation JCOG0509 Coordinating Office Kobe University Hospital Department of Respiratory Medicine
scientific contact
Name Miyako Satouchi MD
Address 13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan Japan
Telephone 078-382-5846
Affiliation Hyogo Cancer Center Department of Respiratory Medicine