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Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Sponsor: University Hospital, Strasbourg, France
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.
Official title: A Phase II Multicentric, Randomized Trial Assessing Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Key Details
Gender
All
Age Range
13 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-03-04
Completion Date
2029-06
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
Cryoablation
Percutaneous imaging-guided cryoablation
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
Locations (13)
Service d'oncologie/CHU de Besançon
Besançon, France
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
Bordeaux, France
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
Caen, France
Service d'Oncologie Médicale -Centre Georges François LECLERC
Dijon, France
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
Lyon, France
Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
Marseille, France
Service de Radiologie-CHU de Nantes
Nantes, France
Service d'Oncologie Médicale-Centre Antoine LACASSAGNE
Nice, France
Service d'Oncologie Médicale
Saint-Herblain, France
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, France
Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091
Strasbourg, France
Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse
Toulouse, France
Service d'Oncologie médicale, Service de Radiologie Interventionnelle- Institut Gustave ROUSSY
Villejuif, France