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

Phase 3

Completed

• Conditions: Small-Cell-Lung Cancer
• Interventions: Drug: Irinotecan and cisplatin after chemoradiotherapy; Drug: Etoposide and cisplatin after chemoradiotherapy

• Registration Number: NCT00144989
• Lead Sponsor: Haruhiko Fukuda

Brief 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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Irinotecan and cisplatin after chemoradiotherapy	Irinotecan and cisplatin after chemoradiotherapy
1	Etoposide and cisplatin after chemoradiotherapy	Etoposide and cisplatin after chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
overall survival	during the study conduct

Secondary Outcome Measures

Name	Time	Method
adverse events of induction chemoradiotherapy	during the study conduct
progression-free survival	during the study conduct
late radiation morbidity	during the study conduct
serious adverse event	during the study conduct
chemotherapy after chemoradiotherapy	during the study conduct

Trial Locations

Locations (37)

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

Aichi Cancer Center,Aichi Hospital; 🇯🇵 Okazaki,Kake-machi,Kuriyado,18, Aichi, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

Kyushu University Hospital; 🇯🇵 Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

Gifu Municipal Hospital; 🇯🇵 Gifu,Kashima-cho,7-1, Gifu, Japan

Gunma Prefectural Cancer Center; 🇯🇵 Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan

National Nishigunma Hospital; 🇯🇵 Shibukawa,Kanai,2854, Gunma, Japan

National Hospital Organization, Dohoku National Hospital; 🇯🇵 Asahikawa,Hanasaki,7-4048, Hokkaido, Japan

National Hospital Organization Hokkaido Cancer Center; 🇯🇵 Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan

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