Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Chemoembolization with Doxorubicin: * 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).

Study 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.

Eligibility

Primary outcome measure(s)

• Volume reduction in cm — 1 year
  Reduction of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.
• Reduction of pain (VAS score) — 1 year
  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.
• Reduction of antalgic therapy (mg) — 1 year
  Mean reduction in the use of pain medications evaluated in mg of active ingredient taken daily before the treatment and at follow-up.

Trial sites (1)

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