UMIN ID: C000000075
Registered date:25/08/2005
A Phase III Study of Intra-Arterial Hepatic Chemotherapy with 5-FU (WHF) in Patients with Liver Metastases from Colorectal Carcinoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Liver excision;liver metastasis cancer of colorectal cancer origin |
| Date of first enrollment | 2005/02/01 |
| Target sample size | 280 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Hepatic arterial infusion of 5-FU 1000mg/m2 once a week for 6 months, followed by UFT 300mg/m2/day and leucovorin 75mg/day until 1 year after surgery UFT 300mg/m2/day and leucovorin 75mg/day until 1 year after surgery |
Outcome(s)
| Primary Outcome | disease free survival |
|---|---|
| Secondary Outcome | survival, recurrence in residual liver, recurrence in extrahepatic lesion, adverse events |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) active synchronous or metachronous malignancy other than carcinoma in situ 2) serious postoperative complications 3) serious coexisting illness a; diabetes mellitus, uncontrolled or controlled with insulin b; uncontrolled hypertension c; history of myocardial infarction, unstable angina within 6 months prior to the registration d; liver cirrhosis e; severe pulmonary dysfunction 4) pregnant or nursing 5) severe mental disorders 6) not suitable for participating in the study for any other reason |
Related Information
| Primary Sponsor | Japanese Foundation for Multidisciplinary Treatment of Cancer |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japanese Foundation for Multidisciplinary Treatment of Cancer |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan |
| Telephone | 03-5627-7594 |
| jfmc-dc@jfmc.or.jp | |
| Affiliation | Japanese Foundation for Multidisciplinary Treatment of Cancer Office |
| scientific contact | |
| Name | Mitsuo Kusano |
| Address | 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan Japan |
| Telephone | |
| Affiliation | Showa University, School of Medicine Department of Surgery, Division of General & Gastroenterological Surgery |