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) studied | Limited-Stage Small-Cell Lung Cancer |
| Date of first enrollment | 2002/09/01 |
| Target sample size | 270 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A: 3 courses of etoposide and cisplatin after induction chemoradiotherapy B: 3 courses of irinotecan and cisplatin after induction chemoradiotherapy |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome | adverse events of induction chemoradiotherapy, chemotherapy after chemoradiotherapy, late radiation morbidity, serious adverse event, progression-free survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00144989 |
Contact
| public contact | |
| Name | Kaoru Kubota, MD |
| Address | 5-1-1 Tsukiji Chuo-ku Tokyo, 104-0045 JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| 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 |
| Telephone | |
| Affiliation | National Cancer Center Hospital East Thoracic Oncology Division |