A Phase II/III Study Comparing Carboplatin and Irinotecan (CI) with Carboplatin and Etoposide (CE) for the Treatment of Elderly Extended-Stage Small-Cell Lung Cancer (JCOG1201/TORG1528, Elderly ED-SCLC/CI vs. CE)
Phase 2
- Conditions
- Elderly patients with extended-stage small-cell lung cancer
- Registration Number
- JPRN-UMIN000012605
- 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
- 370
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 1 years) malignancies 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Psychiatric disease 5) Patients requiring systemic steroid medication (>= 5 mg/day of prednisolone) 6) Poorly controlled diabetes mellitus (HbAic >= 8.0%) 7) Poorly controlled hypertension 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia or pulmonary fibrosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase III: Overall survival, Phase II: Response rate of CI arm
- Secondary Outcome Measures
Name Time Method Phase III: Progression-free survival, Response rate, Adverse events, Serious adverse events, Symptom score Phase II: Adverse events