NIPH Clinical Trials Search

UMIN ID: C000000051

Registered date:08/08/2005

A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMetastatic colorectal cancer isolated in the liver
Date of first enrollment2003/11/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients undergo implantation of hepatic arterial catheter and port system percutaneously, and then, receive hepatic arterial administration of 5-fluorouracil at day 1,8, and 15 followed by intravenous administration of irinotecan hydrochloride at day 1 and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.


Primary OutcomeAdverse events
Secondary OutcomeTumor response, adverse events, tumor response in the liver, induction rate of hepatic arterial chemotherapy

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) Massive pleural effusion or massive ascites. 2) Active bleeding from digestive organ. 3) Active infection. 4) Watery diarrhea. 5) Other uncontrolled severe illness. 6) Active other malignancy. 7) Prior radiation therapy for abdomen. 8) Positive hepatitis-B antigen or anti-hepatitis-C antibody. 9) Allergy to iodine contrast medium resulting in preclusion of angiography. 10) Severe mental disorder. 11) Pregnant or nursing. 12) Prior placement of hepatic arterial catheter and port system.

Related Information


public contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
Affiliation JCOG0208DI, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Atsushi Ohtsu
Address 6-5-1 Kashiwanoha, Kashiwa 277-8577, Japan Japan
Telephone 04-7133-1111
Affiliation National Cancer Center Hospital East Division of Gastrointestinal Oncology