UMIN ID: C000000130
Registered date:12/09/2005
Phase II study of topotecan and amrubicin for metastatic or relapsed small-cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Metastatic or relapsed small-cell lung cancer |
| Date of first enrollment | 2004/04/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Combination chemotherapy of topotecan and amrubicin |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | Adverse events, overall survival, progression-free survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Active concomitant malignancy Active interstitial pneumonia Massive effusions Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Inappropriate condition for this study judged by physicians. |
Related Information
| Primary Sponsor | Okayama Lung Cancer Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Katsuyuki Hotta |
| Address | 2-5-1 Shikata-cho, Okayama 700-8558 Japan |
| Telephone | 086-235-7227 |
| khotta@md.okayama-u.ac.jp | |
| Affiliation | Okayama Lung Cancer Study Group Coordinating Office Department of Respiratory Medicine, Okayama University Hospital |
| scientific contact | |
| Name | Mitsune Tanimoto |
| Address | 2-5-1 Shikata-cho, Okayama 700-8558 Japan |
| Telephone | 086-235-7227 |
| Affiliation | Okayama University Hospital Hematology, Oncology, Respiratory Medicine |