Metastatic colorectal cancer isolated in the liver
Conditions
Interventions
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 intravenou
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable liver metastases from histologically confirmed colorectal cancer. 2) D1 or D2 resection for primary lesion and no extra-hepatic lesions on images. 3) No prior chemotherapy or more than 3 months interval after adjuvant chemotherapy. 4) Measurable lesion according to RECIST. 5) Ages 20 years and above, 70 years or less. 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. 8) Expected survival more than 8 weeks. 9) Written informed consent.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response, adverse events, tumor response in the liver, induction rate of hepatic arterial chemotherapy | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JCOG0208DI, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed