A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)
Phase 3
- Conditions
- Sensitive relpased small-cell lung cancer
- Registration Number
- JPRN-UMIN000000828
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
Not provided
Exclusion Criteria
1) no active concomitant malignancy 2) pregnancy or lactation 3) serious psychiatric illness 4) steroid treatment 5) massive pleural or pericardial effusion 6) symptomatic brain metastasis 7) interstitial pneumonia or severe pulmonary emphysema 8) diarrhea 9) ileus 10) myocardial infarction within 6 months or unstable angina 11) uncontrollable hypertension 12) uncontrollable diabetes mellitus 13) active infection
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, adverse events, response rate