Colorectal Cancer Clinical Trial
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
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.
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.
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