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

Haruhiko Fukuda281 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

281

Conditions

Small-Cell-Lung Cancer

Interventions

Etoposide and cisplatin after chemoradiotherapyDRUG

Etoposide and cisplatin after chemoradiotherapy

Irinotecan and cisplatin after chemoradiotherapyDRUG

Irinotecan and cisplatin after chemoradiotherapy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.