Cryotherapy in the Treatment of Desmoid Tumors

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.

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Key information

Conditions

Desmoid Desmoid Tumors Fibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location status: Recruiting

Location contact

Costantino Errani, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cryotherapy

Procedure

The 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.

Primary outcomes

response to treatment

Time frame: At baseline (time 0)

assessment of tumor response to treatment will be performed using the solid tumor response criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Costantino Errani, MD

CONTACT

[email protected]

051-6366 ext. 6103

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Oct 25, 2021
Registry last updated: Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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