NCT06081400

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

A Phase II Multicentric, Randomized Trial Assessing Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Desmoid Tumor

Interventions

Type	Name	Description
PROCEDURE	Cryoablation	Percutaneous imaging-guided cryoablation
DRUG	Chemotherapy drug	Either : methotrexate 30mg/m² + vinblastine 6mg/m² (IV infusion) once/week for 6 months, then every other week from months 7 to 12, or vinorelbine : for adults : 90mg/week (per os: 3x30mg, soft capsules) for 12 months; for adolescents: 60mg/m2/week (capped at 90mg/week) for 12 months

Timeline

• Start date: 2024-03-04
• Primary completion: 2027-03-01
• Completion: 2029-06-01
• First posted: 2023-10-13
• Last updated: 2025-11-19

Locations

13 sites across 1 country: France