Overview

This trial is active, not recruiting.

Condition small-cell-lung cancer
Treatments etoposide and cisplatin after chemoradiotherapy, irinotecan and cisplatin after chemoradiotherapy
Phase phase 3
Sponsor Japan Clinical Oncology Group
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date September 2002
End date September 2011
Trial size 281 participants
Trial identifier NCT00144989, C000000095, JCOG0202-MF

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Etoposide and cisplatin after chemoradiotherapy
etoposide and cisplatin after chemoradiotherapy
Etoposide and cisplatin after chemoradiotherapy
(Experimental)
Irinotecan and cisplatin after chemoradiotherapy
irinotecan and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapy

Primary Outcomes

Measure
overall survival
time frame: during the study conduct

Secondary Outcomes

Measure
adverse events of induction chemoradiotherapy
time frame: during the study conduct
chemotherapy after chemoradiotherapy
time frame: during the study conduct
late radiation morbidity
time frame: during the study conduct
serious adverse event
time frame: during the study conduct
progression-free survival
time frame: during the study conduct

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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.

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Japan Clinical Oncology Group.