NIPH Clinical Trials Search

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) studiedLiver excision;liver metastasis cancer of colorectal cancer origin
Date of first enrollment2005/02/01
Target sample size280
Countries of recruitmentJapan
Study typeInterventional
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


Primary Outcomedisease free survival
Secondary Outcomesurvival, recurrence in residual liver, recurrence in extrahepatic lesion, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
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
Affiliation Showa University, School of Medicine Department of Surgery, Division of General & Gastroenterological Surgery