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)
- Conditions
- extensive-disease small cell lung cancer
- Registration Number
- JPRN-UMIN000000720
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 282
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method progression-free survival, response rate, diarrhea(Grade3/4), adverse events, QO