Cryotherapy in the Treatment of Desmoid Tumors
ConditionDesmoid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli
About this trial
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologic diagnosis of desmoid tumors
age > 18 years
abdominal and extra-abdominal desmoid tumors
Disqualifiers
contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
retroperitoneal desmoid tumors
age < 18 years
Trial design
Design model
Single group
Treatments tested in this trial
Cryotherapy
Procedure/SurgeryThe procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.
Treatment groups
94 Participants
are divided into 1 treatment groupGroup A: PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
response to treatment
assessment of tumor response to treatment will be performed using the solid tumor response criteria
Time frame
At baseline (time 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov