UMIN ID: UMIN000002379
Registered date:26/08/2009
A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Lung Cancer |
| Date of first enrollment | 2009/08/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | PTX 70mg/m2 VNR 20mg/m2 every 3 weeks 2-6 courses |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome | Overall survival,safety, toxicity, QOL |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1 active concomitant malignancies or infections 2 past history of severe allergic reactions to drugs 3 other serious complications, such as interstitial pneumonia identified by chest X-ray, uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled diabetes mellitus, liver cirrhosis or hypertension |
Related Information
| Primary Sponsor | Niigata Lung Cancer Treatment Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hirohisa Yoshizawa |
| Address | 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520 Japan |
| Telephone | 025-227-2517 |
| hy0522@med.niigata-u.ac.jp | |
| Affiliation | Niigata University Medical and Dental Hospital Bioscience Medical Research Center |
| scientific contact | |
| Name | Hirohisa Yoshizawa |
| Address | 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520 Japan |
| Telephone | 025-227-2517 |
| hy0522@med.niigata-u.ac.jp | |
| Affiliation | Niigata University Medical and Dental Hospital Bioscience Medical Research Center |