Pathological stage I-IIIA completely resected pulmonary high-grade neuroendocrine carcinoma
Conditions
Interventions
A: 4 cycles of adjuvant chemotherapy with etoposide (100 mg/m2/day, day 1-3) and cisplatin (80 mg/m2/day, day 1) repeated every 3 weeks
B: 4 cycles of adjuvant chemotherapy with irinotecan (60 mg/m2/d
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven high-grade neuroendocrine carcinoma (small cell carcinoma including combined small cell carcinoma or large cell neuroendocrine carcinoma including combined large cell neuroendocrine carcinoma) 2) Pathological stage I-IIIA based on the TNM classification 2009 3) Pathologically proven either of R0, R1 (is), or R1 (cy+) 4) Aged 20 to 74 years old 5) ECOG performance status of 0 or 1 6) Lobectomy or more extended surgery was performed 7) ND 2a-1 or more extended lymph node dissection was performed. 8) Within 28 to 56 days after surgery 9) No distant metastases including brain metastasis 10) No prior chemotherapy or radiotherapy for any other cancers 11) Adequate organ functions 12) Diarrhea and intestinal obstruction of grade 1 or less based on CTCAE v4.0. 13) Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, Proportion of treatment completion, Adverse events, Serious adverse events, Second malignancy | — |
Countries
Japan
Contacts
Public ContactKenmotsu Hirotsugu
JCOG1205/1206 Coordinating Office Division of Thoracic Oncology, Shizuoka Cancer Center
Outcome results
None listed