UMIN ID: C000000436
Registered date:23/06/2006
A phase II study of Iressa and vinorelbine/gemcitabine in chemo-naive elderly patients with advanced non-small-cell lung cancer screened for EGFR mutation status.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non-small-cell lung cancer |
| Date of first enrollment | 2006/06/01 |
| Target sample size | 88 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Patients whose tumor has an EGFR mutation are treated with gefitinib. Patients whose tumor has a wild-type EGFR are treated with vinorelbine or gemcitabine. |
Outcome(s)
| Primary Outcome | Response rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 70years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Symptomatic brain metastasis 2.Patients who received previous chemotherapy 3.Overt interstitial pneumonia in chest CT |
Related Information
| Primary Sponsor | IVAN Investigators |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyoto University Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shiro Fujita |
| Address | Japan |
| Telephone | |
| sfujita@kuhp.kyoto-u.ac.jp | |
| Affiliation | Kyoto University Hospital Department of Respiratory Medicine |
| scientific contact | |
| Name | Tadashi Mio |
| Address | 54 Shogoin Kawaracho, Sakyo-ku, Kyoto, Japan Japan |
| Telephone | |
| Affiliation | Kyoto University Hospital Department of Respiratory Medicine |