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Evaluation of the Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity After Brachytherapy of Liver Metastases From Colorectal Carcinoma, Assessed in a Prospective Randomised Trial

Phase 2
18 Years
80 Years
Open (Enrolling)
Colorectal Cancer, Liver Metastases, Irradiation Damage, Radiation Induced Liver Disease

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Trial Information

Evaluation of the Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity After Brachytherapy of Liver Metastases From Colorectal Carcinoma, Assessed in a Prospective Randomised Trial

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 percutaneous liver irradiation and on bone marrow transplantation.
However, data remains inconclusive.

This exploratory study aims at assessing whether a protective effect of the combination of
pentoxifylline, ursodeoxycholic acid and enoxaparin can be demonstrated in a limited number
of patients with liver metastases of colorectal cancer after HDR brachytherapy.

All patients receive a single fraction CT/MRI-guided HDR-brachytherapy of colorectal liver
metastases using Iridium-192 as a standard therapy. The follow-up consists of 4 MRI controls
of the abdomen using the hepatocyte-specific contrast agent Gd-EOB-DTPA (Primovist) after 3
days, 6 weeks, 3 months and 6 months as well as blood samples and a questionnaire taken the
same time.Within the study, 22 patients are given low dose low molecular weight heparin,
pentoxifylline and ursodeoxycholic acid for 8 weeks starting with the preinterventional day.
Another 22 patient will receive the standard therapy without the medication. After
completion of the follow-up, MRI volume data of the lesion will be acquired and compared to
the dosimetric treatment plan. Blood samples are tested for liver-specific and inflammatory
laboratory parameters.

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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

HDR-brachytherapy isodose (measured in Gy) that corresponds to the metastases without enhancement of Gd-EOB-DTPA in MR imaging using an axial T1 THRIVE sequence.

Outcome Description:

The primary variable is the HDR-brachytherapy isodose that encloses liver tissue with a diminished uptake of the hepatocyte selective contrast agent GD-EOB-DTPA. By identifying the damaged volume in every layer of the axial T1 THRIVE image, 3D data can be calculated and correlated to a specific isodose when merged with the 3D irradiation treatment plan. Prior to brachytherapy, the baseline volume of the metastases will be measured instead of the liver tissue damaged by irradiation.

Outcome Time Frame:

One day prior to brachytherapy.

Safety Issue:


Principal Investigator

Jens Ricke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Magdeburg, Faculty for Medicine


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Liver Metastases
  • Irradiation Damage
  • Radiation Induced Liver Disease
  • brachytherapy
  • liver metastases
  • irradiation
  • radiation induced liver disease
  • dosimetry
  • Colorectal Neoplasms
  • Liver Diseases
  • Neoplasm Metastasis
  • Liver Neoplasms