NCT00144989

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

A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Haruhiko Fukuda · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Small-Cell-Lung Cancer

Interventions

Type	Name	Description
DRUG	Etoposide and cisplatin after chemoradiotherapy	Etoposide and cisplatin after chemoradiotherapy
DRUG	Irinotecan and cisplatin after chemoradiotherapy	Irinotecan and cisplatin after chemoradiotherapy

Timeline

• Start date: 2002-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2005-09-05
• Last updated: 2016-09-22

Locations

37 sites across 1 country: Japan