Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

NCT06268457 | Recruiting

• 1 other identifier: CE-AVEC 789/2023/Oss/IOR
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular.

Conditions

Desmoid

Keywords

Chemoembolization

Outcome Measures

Primary Outcomes (3)

• Volume reduction in cm

  Reduction of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.

  1 year

• Reduction of pain (VAS score)

  Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.

  1 year

• Reduction of antalgic therapy (mg)

  Mean reduction in the use of pain medications evaluated in mg of active ingredient taken daily before the treatment and at follow-up.

  1 year

Secondary Outcomes (2)

• Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)

  1 year

• Improvement in quality of life (EORTC QLQ - BM22)

  1 year

Study Arms (1)

Performed chemoembolization

Procedure: Chemoembolization with Doxorubicin

Interventions

Chemoembolization with Doxorubicin PROCEDURE

* Identification of the main vessels afferent to the metastasis to be treated. * Selective and super-selective catheterization of pathological arterial branches, responsible for the blood supply to the neoplasm, through the use of micro-catheters. * Injection of embolizing material (hydrogel microspheres with doxorubicin) * Control of technical success: the embolization will be followed by diagnostic arteriography that will evaluate the success of the procedure (occlusion of more than 90 percent of the pathologic vasculature).

Performed chemoembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by desmoid fibromatoses eligible to be treated with chemoembolization with Doxorubicin

You may qualify if:

• FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)
• Patients who are not candidates for surgery or cryoablation

You may not qualify if:

• Patients with life expectancy \<3 months or severely impaired status functional status (ASA 4)
• Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT)
• Patients with coagulation deficiency or plateletopenic disease
• Patients with documented active infection

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

IT (1)