JPRN-UMIN000010298
Completed
Phase 3
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) - 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)
Japan Clinical Oncology Group (JCOG)0 sites220 target enrollmentMarch 25, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pathological stage I-IIIA completely resected pulmonary high-grade neuroendocrine carcinoma
- Sponsor
- Japan Clinical Oncology Group (JCOG)
- Enrollment
- 220
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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