UMIN ID: C000000346
Registered date:01/04/2006
A randomized clinical trial of adjuvant chemotherapy with TS-1 versus UFT following curative operation for Stage III colorectal cancer
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | stage III colorectal cancer |
| Date of first enrollment | 2005/07/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | UFT 400mg/m2/day 5days' medication, 2days' rest Start medication within 6weeks postoperatively, continue for 12months TS-1 80mg/m2/day 28days' medication, 14days' break Start medication within 6weeks postoperatively, continue for 12months |
Outcome(s)
| Primary Outcome | 3-year disease free survival |
|---|---|
| Secondary Outcome | overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | :patients with hypersensitivity or allergy to any medicine :Pts. with myelosupression, renal dysfuction, or liver dysfuncion :Pts. with severe postoperative complications :Pt. who is pregnant or is to be pregnant :Pts. with multiple cancers :Pts. who are taking other fluoropyrimidine derivatives :Pts. with severe infection or inflammation :doctor's decision for exclusion |
Related Information
| Primary Sponsor | Boso Clinical Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The nonprofit organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Keiji Koda |
| Address | 1-8-1 Inohana, Chuo-Ku, Chiba City, Japan Japan |
| Telephone | 043-293-0086 |
| k-koda@umin.ac.jp | |
| Affiliation | Boso Clinical Oncology Group The nonprofit organization |
| scientific contact | |
| Name | Hisahiro Matsubara |
| Address | 1-8-1 Inohana, Chuo-Ku, Chiba City, Japan Japan |
| Telephone | 043-222-7171 |
| matsuhm@faculty.chiba-u.jp | |
| Affiliation | Boso Clinical Oncology Group The nonprofit organization |