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RECRUITING
NCT06081400
NA

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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

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

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