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

Information source: University of Magdeburg
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer; Liver Metastases; Irradiation Damage; Radiation Induced Liver Disease

Intervention: Pentoxifylline (Drug); Ursodeoxycholic Acid (Drug); Enoxaparin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Magdeburg

Official(s) and/or principal investigator(s):
Jens Ricke, MD, Principal Investigator, Affiliation: University of Magdeburg, Faculty for Medicine

Overall contact:
Max Seidensticker, MD, Phone: +49(0)391-6713030, Email: max.seidensticker@med.ovgu.de

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.

Clinical Details

Official title: 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

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

Primary outcome:

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.

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

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

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

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

Secondary outcome:

Correlation between the HDR brachytherapy isodose that corresponds to damaged live tissue as defined by missing Gd-EOB-DTPA enhancement in MR imaging and liver-specific laboratory values.

Quality of live.

Safety of the study drugs.

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 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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)

Locations and Contacts

Max Seidensticker, MD, Phone: +49(0)391-6713030, Email: max.seidensticker@med.ovgu.de

Clinic for Radiology and Nuclear Medicine, Magdeburg, Sachsen-Anhalt 39120, Germany; Recruiting
Additional Information

Starting date: June 2009
Last updated: June 22, 2010

Page last updated: August 23, 2015

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