drugset / Trial / NCT06081400
Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Recruiting
150 enrolled
University Hospital, Strasbourg, France
Direction Générale de l'Offre des Soins (DGOS) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |