UMIN ID: UMIN000001800
Registered date:31/08/2010
Phase II study of irinotecan and tegafur gimeracil for NSCLC with EGFR mutation which resistant to EGFR-TKI
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Non-small-cell lung cancer |
| Date of first enrollment | 2008/12/01 |
| Target sample size | 25 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | tegafur gimeracil and irinotecan |
Outcome(s)
| Primary Outcome | Disease controll rate at 8 weeks after the initiation of treatment |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Pre-treated with 5-FU related drugs or irinotecan 2. With severe comorbidities 3. With symptomatic brain metastasis 4. Pregnant women |
Related Information
| Primary Sponsor | North Japan Lung Cancer Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | North Japan Lung Cancer Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| akinoue@idac.tohoku.ac.jp | |
| Affiliation | North Japan Lung Cancer Study Group Registration office |
| scientific contact | |
| Name | Shunichi Sugawara |
| Address | 4-15, Hirose-machi, Aobaku, Sendai Japan |
| Telephone | |
| Affiliation | Sendai Kosei Hospital Respiratory medicine |