A Phase III Study Comparing Irinotecan and Cisplatin with Etoposide and Cisplatin for Adjuvant Chemotherapy of Completely Resected Pulmonary High-grade Neuroendocrine Carcinoma (JCOG1205/1206, HGNEC-EP/IP-P3)
- Conditions
- Pathological stage I-IIIA completely resected pulmonary high-grade neuroendocrine carcinoma
- Registration Number
- JPRN-UMIN000010298
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 220
Not provided
1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Pregnant or lactating women or women of childbearing potential 5) Psychiatric disease 6) Serious postoperative complications 7) Patients requiring systemic steroids medication 8) Poorly controlled diabetes mellitus or routine administration of insulin 9) Poorly controlled hypertension 10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 11) Positive HBs antigen 12) Positive HIV antibody 13) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Relapse-free survival, Proportion of treatment completion, Adverse events, Serious adverse events, Second malignancy