drugset / Trial / NCT06081400

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

NCT06081400

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2024-03-04
Primary completion
2027-03
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule 30 mg/m2
Comparator Vinblastine Small molecule 6 mg/m2 Intravenous
Comparator Vinorelbine Small molecule 60 mg/m2 Oral
Comparator Vinorelbine Small molecule 90 mg Oral

Indications