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
This trial does not accept healthy volunteersQualifiers
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 population
Patients affected by desmoid fibromatoses eligible to be treated with chemoembolization with Doxorubicin
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Chemoembolization with Doxorubicin
Procedure/Surgery* 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).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Performed chemoembolization1 intervention
Trial outcomes
Primary outcomes
1
Volume reduction in cm
Reduction of the lesion evaluated with MRI, measuring the diameter of the lesion in cm.
Time frame
1 year2
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.
Time frame
1 year3
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.
Time frame
1 yearSecondary outcomes
1
Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)
Clinical assessment regarding quality of life by EORTC QLQ-C15-PAL questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales.
Time frame
1 year2
Improvement in quality of life (EORTC QLQ - BM22)
Clinical assessment regarding quality of life by EORTC QLQ - BM22 questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov