NIPH Clinical Trials Search

UMIN ID: C000000095

Registered date:30/08/2005

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 the Treatment of Limited-Stage Small-Cell Lung Cancer (EP/TRT-IPIII): JCOG0202-MF

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedLimited-Stage Small-Cell Lung Cancer
Date of first enrollment2002/09/01
Target sample size270
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: 3 courses of etoposide and cisplatin after induction chemoradiotherapy B: 3 courses of irinotecan and cisplatin after induction chemoradiotherapy


Primary Outcomeoverall survival
Secondary Outcomeadverse events of induction chemoradiotherapy, chemotherapy after chemoradiotherapy, late radiation morbidity, serious adverse event, progression-free survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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.

Related Information


public contact
Name Kaoru Kubota, MD
Address 5-1-1 Tsukiji Chuo-ku Tokyo, 104-0045 JAPAN Japan
Affiliation JCOG0202 Coordinating Office Thoracic Oncology Division, National Cancer Center Hospital
scientific contact
Name Yutaka Nishiwaki, MD
Address 6-5-1 kashiwanoha Kashiwa-shi Chiba,277-8577 JAPAN Japan
Affiliation National Cancer Center Hospital East Thoracic Oncology Division