Preventive effect of drugs on radiation damage to the liver.

Evaluation of the preventive effect of pentoxifylline and ursodeoxycholic acid to radiation induced liver toxicity after brachytherapy of liver metastases, assessed in a prospective randomised trial. - ELDORADO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002985-70-DE

Enrollment

Registered

2008-12-17

Start date

2009-04-23

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irradiation damage to the liver after HDR-brachytherapy of liver metastases.

Interventions

Trade Name: Trental Product Name: Trental Pharmaceutical Form: Modified-release tablet INN or Proposed INN: PENTOXIFYLLINE CAS Number: 6493-05-6 Trade Name: Ursofalk Product Name: Ursofalk Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 to 85 or ECOG performance status of 0 or 1 If female, postmenopausal or surgically sterilized Liver metastases scheduled for a CT/MRI-guided single or sequential 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

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 Primovist, Ursodeoxycholic acid and/or Pentoxifylline Any prior irradiation therapy of the liver up to 6 months before inclusion Close affiliation with the investigational site; e.g. a close relative of the investigator Severe coronary artery disease Autoimmune diseases Acute bacterial endocarditis Patients with severe renal impairment (GFR below 45 mL/min/ according to the CKI EPI formula, calculated from a creatinine value obtained at the initial examination) Patients with medication of coumarins (vitamin K antagonists)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess if a combination regimen of pentoxifylline and ursodeoxycholic acid provides a preventive effect regarding irradiation damage to liver parenchyma after HDR-brachytherapy.;Secondary Objective: To evaluate the relation between hepatocyte dysfunction as assessed in Primovist-enhanced MRI and changes in liver-specific and inflammatory laboratory values. To evaluate the quality of live comparing both patient groups using the EQ-5D questionnaire and ECOG performance status. To assess the safety of the study medication given after HDR brachytherapy. ;Primary end point(s): HDR-brachytherapy isodose that marks the border between damaged and functioning liver tissue (as defined by GD-EOB-DTPA-enhanced MR imaging).;Timepoint(s) of evaluation of this end point: 6 weeks, 3 months and 6 months after brachytherapy.	—

Measure

Time frame

Main Objective: To assess if a combination regimen of pentoxifylline and ursodeoxycholic acid provides a preventive effect regarding irradiation damage to liver parenchyma after HDR-brachytherapy.;Secondary Objective: To evaluate the relation between hepatocyte dysfunction as assessed in Primovist-enhanced MRI and changes in liver-specific and inflammatory laboratory values. To evaluate the quality of live comparing both patient groups using the EQ-5D questionnaire and ECOG performance status. To assess the safety of the study medication given after HDR brachytherapy. ;Primary end point(s): HDR-brachytherapy isodose that marks the border between damaged and functioning liver tissue (as defined by GD-EOB-DTPA-enhanced MR imaging).;Timepoint(s) of evaluation of this end point: 6 weeks, 3 months and 6 months after brachytherapy.

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in inflammatory and liver specific parameters. Quality of live as assessed by EQ-5D questionnaire und ECOG performance status.;Timepoint(s) of evaluation of this end point: 6 weeks, 3 months and 6 months after brachytherapy.	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026