Status:
COMPLETED
Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity
Lead Sponsor:
University of Magdeburg
Collaborating Sponsors:
Sirtex Medical
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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.
Detailed Description
A preventive effect of pentoxifylline, ursodeoxycholic acid and low dose low molecular weight heparin on pathological processes in healthy tissue after irradiation is described in clinical studies on ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01149304
Start Date
June 1 2009
Last Update
November 20 2017
Active Locations (1)
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1
Clinic for Radiology and Nuclear Medicine
Magdeburg, Saxony-Anhalt, Germany, 39120