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)

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) - 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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000720

Enrollment

282

Registered

2007-05-22

Start date

2007-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extensive-disease small cell lung cancer

Interventions

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 d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) cytologically, histologically proven small-cell lung cancer 2) extensive disease 3) age 20-70 years old 4) performance status of 0-1 5) measurable or unmeasurable disease 6) no prior chemotherapy or radiation treatment for cancer 7) adequate organ functions 8) requested a patient to answer the QOL qestionaire 9) written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression-free survival, response rate, diarrhea(Grade3/4), adverse events, QOL	—

Countries

Japan

Contacts

Public ContactYoshikazu Kotani MD

JCOG0509 Coordinating Office Kobe University Hospital Department of Respiratory Medicine

JCOG_sir@ml.jcog.jp078-382-5846

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026