Overview

Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR) brachytherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Magdeburg
Collaborator:
Sirtex Medical
Treatments:
Enoxaparin
Pentoxifylline
Ursodeoxycholic Acid
Criteria
Inclusion Criteria:

- Age 18 to 80

- If female, postmenopausal or surgically sterilized

- Liver metastases from colorectal carcinoma scheduled for a CT/MRI-guided
single-fraction interstitial HDR brachytherapy

- Non-cirrhotic liver

- Life expectancy longer than 6 months

- willing and able to undergo all study procedures

- Having voluntarily provided written and fully informed consent

Exclusion Criteria:

- Women who are pregnant, lactating or who are of childbearing potential

- Liver cirrhosis

- Hepatitis B

- Hepatitis C

- Patients being clinically unstable

- Uncooperative, in the investigator's opinion

- Having been previously enrolled in this study

- Participating in another therapy-modulating clinical trial

- Contraindication for MRI

- Contraindication or hypersensitivity to one or more components of Gd-EOB-DTPA,
Enoxaparin, Ursodeoxycholic acid and/or Pentoxifylline

- Any prior irradiation therapy of the liver

- Close affiliation with the investigational site; e.g. a close relative of the
investigator

- Severe coronary artery disease

- Autoimmune diseases

- Acute bacterial endocarditis

- Active major bleedings and high rish of uncontrolled haemorrhage

- Patients with severe or moderate renal impairment (GFR below 60 mL/min/1.73 m2
according to the MDRD or Cockroft-Gault formula, calculated from a creatinine value
obtained within 1 week before each planned Primovist-enhanced MR examination)