Cryotherapy in the Treatment of Desmoid Tumors

Not Applicable

Recruiting

• Conditions: Desmoid
• Interventions: Procedure: Cryotherapy

• Registration Number: NCT05091255
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• histologic diagnosis of desmoid tumors
• age > 18 years
• abdominal and extra-abdominal desmoid tumors

Exclusion Criteria

• contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
• retroperitoneal desmoid tumors
• age < 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Cryotherapy	-

Primary Outcome Measures

Name	Time	Method
response to treatment	At baseline (time 0)	assessment of tumor response to treatment will be performed using the solid tumor response criteria

Trial Locations

Locations (1)

IRCCS Itituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy