Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

ConditionDesmoid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

Qualifiers

FIbromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)

Patients who are not candidates for surgery or cryoablation

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Chemoembolization with Doxorubicin

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators