UMIN ID: UMIN000001560
Registered date:10/12/2008
A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | stage III colorectal cancer |
| Date of first enrollment | 2008/03/01 |
| Target sample size | 140 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | UFT 300mg per m2 per day and LV 75mg per day for 28 days every 5-weeks for 6 months TS-1 80mg per m2 per day for 28 days every 6-weeks for 12 months |
Outcome(s)
| Primary Outcome | 3-year disease free survival rate |
|---|---|
| Secondary Outcome | overall survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Severe postoperative complication 2. Serious coexisting illness 1)uncontrolled diabetes mellitus and hypertension 2)history of myocardial infarction, unstable angina within 6 months prior to the registrationsevere 3)pulmonary dysfunction 3. Active diarrhea 4. Multiple cancer 5. Pregnant 6. Disqualified by attending doctor |
Related Information
| Primary Sponsor | Boso Clinical Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hideaki Miyauchi |
| Address | 1-8-1 Inohana, Chu0-ku, Chiba, Japan Japan |
| Telephone | 043-226-2109 |
| miyahide@faculty.chiba-u.jp | |
| Affiliation | Graduate school of medicine Department of frontier surgery |
| scientific contact | |
| Name | Keiji Koda |
| Address | 3426-3 Anegasaki, Ichihara, Japan Japan |
| Telephone | 0436-62-1211 |
| k-koda@med.teikyo-u.ac.jp | |
| Affiliation | Teikyo University Chiba Medical Center Department of surgery |