Actively Recruiting
Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Led by University Hospital, Strasbourg, France · Updated on 2025-11-19
150
Participants Needed
13
Research Sites
273 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Strasbourg, France
Lead Sponsor
D
Direction Générale de l'Offre des Soins (DGOS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
"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
Official Title
Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female with extra-peritoneal desmoid tumor confirmed by biopsy within the RRePS network
- Age 13 years or older
- Measurable viable tumor by MRI within 2 months before treatment start
- Progressive disease after watchful waiting or significant symptoms requiring treatment
- Tumor accessible for cryoablation procedure at a type I center
- Complete tumor destruction achievable with one cryoablation procedure plus 1cm safety margin
- ECOG performance status between 0 and 2 at inclusion
- Blood counts: neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L; no significant bleeding issues
- Ability to understand study risks and provide informed consent; parental consent if minor
- Affiliated with social health insurance
- Negative pregnancy test for women of childbearing age at screening
- Agreement to use contraception
You will not qualify if you...
- Intra-peritoneal or multifocal desmoid tumor
- Previous or current antitumor treatment for the current desmoid tumor
- Relapse after surgery for desmoid tumor
- Known hypersensitivity to vinorelbine, vinblastine, methotrexate, or related substances
- Severe infection within 2 weeks, severe kidney or liver failure, or chronic respiratory failure
- Hypersensitivity to gadoteric acid or gadolinium-based drugs
- Concurrent use of yellow fever vaccine or certain listed medications
- Tumor size or location making cryoablation unsafe according to radiologist
- Bleeding disorders affecting cryoablation
- Contraindications to sedation or MRI
- Pregnancy or breastfeeding
- Participation in other experimental studies affecting outcomes
- Inability to provide informed consent
- Psychiatric disorders
- Legal protection status limiting consent ability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Service d'oncologie/CHU de Besançon
Besançon, France
Not Yet Recruiting
2
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
Bordeaux, France, 33000
Actively Recruiting
3
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
Caen, France, 14076
Actively Recruiting
4
Service d'Oncologie Médicale -Centre Georges François LECLERC
Dijon, France, 21079
Actively Recruiting
5
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
Lyon, France, 69373
Actively Recruiting
6
Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
Marseille, France, 13385
Actively Recruiting
7
Service de Radiologie-CHU de Nantes
Nantes, France, 44000
Actively Recruiting
8
Service d'Oncologie Médicale-Centre Antoine LACASSAGNE
Nice, France, 06189
Actively Recruiting
9
Service d'Oncologie Médicale
Saint-Herblain, France, 44805
Actively Recruiting
10
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, France, 67033
Actively Recruiting
11
Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091
Strasbourg, France, 67091
Actively Recruiting
12
Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse
Toulouse, France, 31059
Not Yet Recruiting
13
Service d'Oncologie médicale, Service de Radiologie Interventionnelle- Institut Gustave ROUSSY
Villejuif, France, 94800
Actively Recruiting
Research Team
A
Afshin GANGI, MD,PhD
CONTACT
R
Roberto Luigi CAZZATO, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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