Clinical trial · Interventional
Doxorubicin Eluting Intra-arterial Embolization for Aggressive Desmoid Fibromatosis
NCT03966742CI-TRIAL-00057343completedPhase 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)
In this study Drug-eluting microbeads (DEB) loaded with Doxorubicin will be delivered into the target Desmoid Fibromatoses (DF) tissue via selective arterial embolization by angiographic technique. The objective of the study is to demonstrate the safety and efficacy of this treatment.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Fibromatoses | Desmoid Fibromatosis | ALIAS | 0.90 |
| Desmoid | — | UNRESOLVED | — |
| Desmoid Fibromatosis | Desmoid Fibromatosis | ONTOLOGY_EXACT | 0.98 |
| Desmoid Fibromatosis of Skin | — | UNRESOLVED | — |
| Desmoid Neoplasm of Chest Wall | Chest Wall Fibromatosis | ALIAS | 0.90 |
| Desmoid Tumor Caused by Somatic Mutation | — | UNRESOLVED | — |
| Fibromatosis Desmoid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Doxorubin-eluting particle embolization for treatment of Desmoid Fibromatosis.
- interventionNames
- Procedure: Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis
Primary outcomes (3)
- measure
- Objective response rate of tumor size.
- timeFrame
- At baseline ; 6-10 weeks after each treatment
- description
- Response to treatment. Measured by change in tumor size according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria.
- measure
- Objective response rate of tumor biological activity.
- timeFrame
- At baseline ; 6-10 weeks after each treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 3-80 years. 2. Histologically confirmed diagnosis of Desmoids Fibromatosis. 3. After at least one systemic treatment line. Standard first line systemic treatment may include: Methotrexate, Vinblastine, Doxorubicin, Liposomal Doxorubicin (Doxil), NSAIDS or hormonal treatment. If first line treatment is renounced, this treatment decision must be documented. Considering the trend of avoiding surgical treatment, the documentation must include that the treatment decision is not associated to the resectability of the tumor. 4. Karnofsky performance status (PS)\>50% for patients older than 16 years or Lansky PS \>50% for patients under 16 years. 5. At least one measurable lesion, with a long diameter of at least 30mm, with an anatomical location accessible for endovascular treatment. 6. T2 signal increase on MRI. 7. No evidence of prior treatment toxicity, adequate washout period after prior treatment: * 14 days after myelosuppressive chemotherapy treatment. * 7 days after GCSF (Granulocyte colony-stimulating factor), 14 days after Neulastim. * 7 days after targeted/biologic treatment. 8. Female patients of childbearing potential must be willing to use an adequate method of contraception (hormonal, barrier or abstinence) for the treatment period and up to 90 days after the treatment completion. 9. Willing and able to provide written informed consent for the trial. Exclusion Criteria: 1. Participation in another interventional study. 2. Congestive heart failure, characterised by LVEF (Left Ventricular Ejection Fraction) \< 50% or Shortening fracture \< 27%. 3. Previous treatment with anthracycline of a accumulative dose of more than 360 mg/m2. 4. History of allergic reaction attributed to Doxil or doxorubicin treatment. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
References
Publications (1)
- BACKGROUNDElnekave E, Atar E, Amar S, Bruckheimer E, Knizhnik M, Yaniv I, Dujovny T, Feinmesser M, Ash S. Doxorubicin-Eluting Intra-Arterial Therapy for Pediatric Extra-Abdominal Desmoid Fibromatoses: A Promising Approach for a Perplexing Disease. J Vasc Interv Radiol. 2018 Oct;29(10):1376-1382. doi: 10.1016/j.jvir.2018.04.009. Epub 2018 Jul 31. PMID 30075974