A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Camptothecin; Cisplatin; Etoposide; Etoposide phosphate; Irinotecan

Criteria

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.