A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)

INTERVENTION: A: nogitecan (1.0 mg/m2/day) on days 1 through 5 every 3 weeks, for 4 courses B: irinotecan, cisplatin and etoposide (PEI) 1 course (2 weeks) consisted of cisplatin (25 mg/m2, day1, 8), etoposide (60 mg/m2, day1‐3), and irinotecan (90 mg/m2, day8), for 5 courses. After day 8, granulocyte colony‐stimulating factor (G‐CSF) is administered routinely on days when the cytotoxic drugs are not given. CONDITION: Sensitive relpased small‐cell lung cancer PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: progression‐free survival, adverse events, response rate INCLUSION CRITERIA: 1) histologically or cytologically confirmed small‐cell lung cancer 2) received first‐line chemotherapy or chemoradiotherapy with platinum‐based regimen 3) underwent no operation of small‐cell lung cancer 4) relapsed more than 90 days after the completion of first‐line treatment 5) pathologically confirmed local relapse of small‐cell lung cancer, if it was difficult to distinguish from radiation pneumonitis 6) responded to first‐line chemotherapy or chemoradiotherapy (CR or PR) 7) performance status of 0‐2 on the Eastern Cooperative Oncology Group scale 8) age from 20 to 75 years 9) unnecessary to have measurable disease 10) adequate organ function (1) WBC >= 3,000 /mm3 (2) Neutrophil >= 1,500 /mm3 (3) Hemoglobin >= 9.0 g/dL (4) Platelet >= 100,000 /mm3 (5) Total serum bilirubin <= 2.0 mg/dL (6) GOT (AST) <= 100 IU/L (7) GPT (ALT) <= 100 IU/L (8) Serum creatinine <= 1.5 mg/dL (9)