UMIN ID: C000000445
Registered date:05/07/2006
A randomized controlled trial by a parallel group design in a single institution to evaluate the effectiveness of oral adjuvant chemotherapy using uracil-tegafur to prevent recurrence after curative resection of hepatocellular carcinoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Cases with hepatocellular carcinoma, which is removed curatively and surgically |
| Date of first enrollment | 1997/08/01 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Oral administration of uracil-tegafur (300mg/day) for 1 year after curative resection of hepatocellular carcinoma Only follow-up without any anti-cancer and anti-virus therapy after curative resection of hepatocellular carcinoma |
Outcome(s)
| Primary Outcome | Recurrence-free survival |
|---|---|
| Secondary Outcome | Overall survival |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 79years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein, other previous or synchronous malignant disorders, and postoperative dysfunction of any organ |
Related Information
| Primary Sponsor | Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital |
|---|---|
| Secondary Sponsor | None |
| Source(s) of Monetary Support | The Kanae Foundation for Life & Socio-medical Science,None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masatoshi Makuuchi |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-5800-8841 |
| makuuchi-tky@umin.ac.jp | |
| Affiliation | Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division |
| scientific contact | |
| Name | Masatoshi Makuuchi |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-5800-8841 |
| Affiliation | Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division |