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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Small-Cell-Lung Cancer

Intervention / Treatment
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* Drug: Etoposide and cisplatin after chemoradiotherapy
* Drug: Irinotecan and cisplatin after chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Etoposide and cisplatin after chemoradiotherapy | Drug: Etoposide and cisplatin after chemoradiotherapy<br>* Etoposide and cisplatin after chemoradiotherapy<br>|
| Experimental: 2<br>Irinotecan and cisplatin after chemoradiotherapy | Drug: Irinotecan and cisplatin after chemoradiotherapy<br>* Irinotecan and cisplatin after chemoradiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events of induction chemoradiotherapy |  | during the study conduct | 
| chemotherapy after chemoradiotherapy |  | during the study conduct | 
| late radiation morbidity |  | during the study conduct | 
| serious adverse event |  | during the study conduct | 
| progression-free survival |  | during the study conduct | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small-cell lung cancer, Limited-Stage Small-Cell Lung Cancer, Combined modality therapy, chemotherapy, radiotherapy, Irinotecan, Cisplatin