Status:
COMPLETED
A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Small-Cell-Lung Cancer
Eligibility:
All Genders
20-70 years
Phase:
PHASE3
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 hyper...
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 ...
Eligibility Criteria
Inclusion
- cytologically, histologically proven small-cell lung cancer
- limited disease
- age 20-70 years old
- performance status of 0-1
- measurable disease
- no prior treatment for small-cell lung cancer
- no history of chemotherapy
- adequate organ functions
- written informed consent
Exclusion
- pericardial effusion
- active concomitant malignancy
- pregnant or lactating women
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00144989
Start Date
September 1 2002
End Date
September 1 2011
Last Update
September 22 2016
Active Locations (37)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan, 444-0011
3
National Cancer Center Hospital East
Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007