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)

UMIN ID: C000000051

Registered date:08/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Metastatic colorectal cancer isolated in the liver
• Date of first enrollment: 2003/11/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Tumor response, adverse events, tumor response in the liver, induction rate of hepatic arterial chemotherapy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare