• adverse events of induction chemoradiotherapy [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
• chemotherapy after chemoradiotherapy [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
• late radiation morbidity [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
• serious adverse event [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
• progression-free survival [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

• adverse events of induction chemoradiotherapy
• chemotherapy after chemoradiotherapy
• late radiation morbidity
• serious adverse event
• progression-free survival

To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.

The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.

• Drug: Etoposide and cisplatin after chemoradiotherapy
• Drug: Irinotecan and cisplatin after chemoradiotherapy

• Active Comparator: Etoposide and cisplatin after chemoradiotherapy
• Experimental: Irinotecan and cisplatin after chemoradiotherapy

Inclusion Criteria:

1. cytologically, histologically proven small-cell lung cancer
2. limited disease
3. age 20-70 years old
4. performance status of 0-1
5. measurable disease
6. no prior treatment for small-cell lung cancer
7. no history of chemotherapy
8. adequate organ functions
9. written informed consent

Exclusion Criteria:

1. pericardial effusion
2. active concomitant malignancy
3. pregnant or lactating women
4. interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.