NCT06081400 Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

Trial Parameters

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Brief Summary

"Wait \& see" is currently the standard of care of recently diagnosed desmoid tumors (DT). In case of progression or symptomatic disease, medical therapy is nowadays widely used including chemotherapy. Cryoablation has proven to be beneficial for the treatment of large, progressive and symptomatic DT. This randomized phase II trial aims to compare cryoablation versus medical therapy in DT patients progressing after the "wait \& see" period. Moreover, a cross-over design has been anticipated to allow all patients to undergo cryoablation if necessary.

Eligibility Criteria

Inclusion Criteria: * Subject (male or female) with extra-peritoneal desmoid tumor (confirmed by prior biopsy by an experienced pathologist within the RRePS network) * 13 years of age or older * Measurable viable tumor (according to the mRECIST criteria using MRI. The baseline MRI imaging is mandatory in the 2 months prior to treatment initiation (D0). * Progressive disease (according to the mRECIST criteria) after the watchful waiting period or significant increase in symptoms requiring an active therapy, as advised in a multidisciplinary sarcoma tumor board * Tumor deemed accessible for cryoablation procedure by the operator in a type I center. (In pediatric cases, a careful site tumor analysis will be performed with interventional radiologist to ensure for limited consequence of cryoablation in pediatric patients especially regarding growth plates). * 100 % of destruction of the tumor achievable in one procedure of cryoablation with 1cm security margin according to assessment by ref

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