Clinical trial · Interventional
Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity
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
NCT01149304CI-TRIAL-00030446ELDORADOcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Irradiation Damage | — | UNRESOLVED | — |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Radiation Induced Liver Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin | Drug | — | UNRESOLVED |
| Pentoxifylline | Drug | — | UNRESOLVED |
| Ursodeoxycholic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Medication group with patients receiving the study medication according to the study protocol for 8 weeks after HDR brachytherapy.
- interventionNames
- Drug: Pentoxifylline
- Drug: Ursodeoxycholic Acid
- Drug: Enoxaparin
- type
- NO_INTERVENTION
- label
- Group B
- description
- Comparison group with patients receiving the standard therapy of HDR brachytherapy without the study specific medication.
Primary outcomes (5)
- 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.
- timeFrame
- One day prior to brachytherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTSeidensticker M, Seidensticker R, Damm R, Mohnike K, Pech M, Sangro B, Hass P, Wust P, Kropf S, Gademann G, Ricke J. Prospective randomized trial of enoxaparin, pentoxifylline and ursodeoxycholic acid for prevention of radiation-induced liver toxicity. PLoS One. 2014 Nov 13;9(11):e112731. doi: 10.1371/journal.pone.0112731. eCollection 2014. PMID 25393877