UMIN ID: C000000135
Registered date:08/09/2005
A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non-small cell lung cancer |
| Date of first enrollment | 2005/03/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The treatment schedule included carboplatin AUC 4 on day 1, and gemcitabine 1000 mg/ m2 on days 1 and 8, every 3 weeks. (Below six courses more than three courses.) |
Outcome(s)
| Primary Outcome | Response Rate(according to RECIST criteria) |
|---|---|
| Secondary Outcome | Median survival time, 1-year survival, Adverse events, Time to Progression, Quality of Life |
Key inclusion & exclusion criteria
| Age minimum | 70years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)After thoracic irradiation 2)A case having severe infection and a serious complication 3)Requiring treatment pleural/ascites /pericardial effusion, 4)Interstitial pneumonia or active lung fibrosis on chest X-ray, 5)Symptomatic brain metastases 6)Double cancer 7)Others |
Related Information
| Primary Sponsor | Institute of Biomedical Research and Innovation |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takashi Nishimura |
| Address | 4-6,Minatojima-Nakamachi,Chuo-ku,Kobe 650-0046 Japan Japan |
| Telephone | 078-302-4321 |
| t-nishi@kcgh.gr.jp | |
| Affiliation | Kobe City General Hospital Respiratory Medicine |
| scientific contact | |
| Name | Nobuyuki Katakami |
| Address | 2-2,Minatojima-Minamimachi,Chuo-ku,Kobe 650-0047 Japan Japan |
| Telephone | 078-304-5200 |
| Affiliation | Institute of Biomedical Research and Innovation Department of Translational Research Division of Integrated Oncology |