UMIN ID: C000000116
Registered date:06/09/2005
randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | stage IB-IIIA non small cell lung cancer after complete resection |
| Date of first enrollment | 2001/06/01 |
| Target sample size | 600 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 cycle standard arm: UFT 250mg/m2, daily for 1 year |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.small cell lung cancer or low grade malignancy of lung cancer 2.incomplete resection 3.apparant interstitial pneumonitis at chest rentogenogram 4.inadequate conditon for chemotherapy |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Hirohito Tada, MD. |
| Address | Miyakojima Hondhori 2-13-22 Japan |
| Telephone | |
| Affiliation | Osaka City General Hospital Division of Thoracic Surgery |