Radiofrequenccy Ablation Combined with Hepatic Arterial Embolization using Degradable Starch Microsphere-MitomycinC for the Treatment of Liver Metastasis from Colorectal cancer.

Radiofrequenccy Ablation Combined with Hepatic Arterial Embolization using Degradable Starch Microsphere-MitomycinC for the Treatment of Liver Metastasis from Colorectal cancer. - DRAM study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006404

Enrollment

Registered

2011-09-26

Start date

2011-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer liver metastasis

Interventions

Radiofrequency ablation will be done after hepatic arterial embolization with degradable starchmicrosphere and mitomycinC. Twenty-five patients with colorectal cancer livr metastasis will be treated a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosis of colorectal liver metastasis is histologically or radiologically established. Patients are not surgical candidates or they decline surgical intervention. 2) Primary lesion is controlled. 3) Liver tumors are 3 or fewer with a maximum diameter of 3cm or smaller or, a single with a maximum diamter of 5cm or smaller. 4) No extraheopatic metastasis or controllable even it exists. 5) Liver tumors are not adjacent to the common bile duct or main portal vein. 6) No bile duct abnormality. 7) Age of 20 years or older. 8) ECOG PS of 0 or 1. 9) At least 4 weeks interval from previous treatments. 10) Function of main organs are well preserved. 11) Infromed consent is given from the patient.

Exclusion criteria

Exclusion criteria: 1) Uncontrollable extrahepatic metastasis. 2) Venous invasion. 3) Artrial-portal or -venous shunting. 4) Hepatic arterial obstruction that may prevent embolization. 5) History of billiary surgery. 6) Tumors are close to the bowel and it is difficult to separate them. 7) Herat failure, Renal failure, and active infection, GI bleeding, double cancers, mental disease. 8) Fever (>38 degree celcius). 9) Allergy to contrast medium or mitomycinC. 10) Pregnant woman or woman who is willing to be pregnant. 11) Other reasons that a primary doctor judges judges as inappropriate for a candidate of thi study.

Design outcomes

Primary

Measure	Time frame
Local tumo control	—

Secondary

Measure	Time frame
Adverse effect, local recurrence per lesion, change in tumor marker, Overall survival, 2-year survival rate, local tumor recurrence-free survival, recurrence-free survival, radiological findings.	—

Countries

Japan

Contacts

Public ContactHaruyuki Takaki

Mie University Hospital Department of Interventional Radiology

yama@clin.medic.mie-u.ac.jp+81-59-231-5029

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026