UMIN ID: C000000109
Registered date:02/09/2005
A Phase II Study of Cisplatin, Etoposide and Concurrent Thoracic Irradiation Followed by Irinotecan and Cisplatin in Patients with Limited Small-Cell Lung Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | LD-SCLC |
| Date of first enrollment | 2001/01/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cisplatin and etoposide with concurrent twice-daily thoracic irradiation followed by 3 cycles of cisplatin and irinotecan |
Outcome(s)
| Primary Outcome | Two-year survival rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Clinically apparent interstitial pneumonitis or pulmonary fibrosis 2. Emphysema, chronic bronchitis or bronchial asthma which precludes thoracic radiotherapy 3. Malignant pleural effusion or malignant pericardial effusion 4. Active concomitant or a recent (<3 years) history of any malignancy 5. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <3 months before enrollment or congestive heart failure 6. Uncontrolled diabetes mellitus 7. Uncontrolled severe active infection 8. Intestinal paralysis or obstruction 9. Pregnancy or lactation |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Japan |
| Telephone | 06-6633-7400 |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Hiroshi Saito, M.D. |
| Address | 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan. Japan |
| Telephone | |
| Affiliation | Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine |