UMIN ID: UMIN000001510
Registered date:18/11/2008
A phase II randomized trial in completely resected non-small cell lung cancer comparing paclitaxel / carboplatin with TS-1
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | non-small cell lung cancer |
| Date of first enrollment | 2008/11/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A: paclitaxel 120mg/m2 + carboplatin AUC 3, day1 and day15, q4w, 4 course B: TS-1 80mg/m2 oral, day1 to 14, q3w, 1 year |
Outcome(s)
| Primary Outcome | 2-year relapse free survival |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 76years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) apparent interstitial pneumonitis or pulmonary fibrosis 2) uncontroled pleural effusion or ascitis 3) multiple lung cancer 4) concomittant malignanct 5) past history of radiotherapy or chemotherapy 6) active infection or uncontroled complication 7) past history of severe allergic reaction 8) Pregnant or expecting woman 9) other conditions not suitable for this study |
Related Information
| Primary Sponsor | Nagoya City University thoracic oncology study group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nagoya City University Graduate school of Medical Sciences |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Motoki Yano |
| Address | Japan |
| Telephone | |
| Affiliation | Nagoya City University Graduate school of Medical Sciences Department of Oncology, Immunology, and Surgery |
| scientific contact | |
| Name | Motoki Yano |
| Address | 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan |
| Telephone | |
| Affiliation | Nagoya City University Hospital Department of thoracic Surgery |