Informations générales (source: ClinicalTrials.gov)
A Phase II Multicentric, Randomized Trial Assessing Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Interventional
N/A
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
mars 2024
juin 2029
02 décembre 2025
"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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Fr�d�ric DESCHAMPS | 15/05/2026 08:45:07 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut de cancérologie Strasbourg Europe (ICANS) - 67033 - Strasbourg 2973783 - France | Jean-Emmanuel KURTZ, MD PhD | Contact (sur clinicalTrials) | |||
| Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091 - 67091 - Strasbourg 2973783 - France | Afshin GANGI, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service de Radiologie-CHU de Nantes - 44000 - Nantes 2990969 - France | Arthur DAVID, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale - 44805 - Saint-Herblain 2979590 - France | Emmanuelle BOMPAS, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale -Centre Georges François LECLERC - 21079 - Dijon 3021372 - France | Alice HERVIEU, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE - 33000 - Bordeaux 3031582 - France | Maud TOULMONDE, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone - 13385 - Marseille 2995469 - France | Florence DUFFAUD, MD, PhD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE - 14076 - Caen 3029241 - France | Marie-Aude THENINT, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD - 69373 - Lyon 2996944 - France | Mehdi BRAHMI, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale-Centre Antoine LACASSAGNE - 06189 - Nice 2990440 - France | Agnès DUCOULOMBIER, MD | Contact (sur clinicalTrials) | |||
| Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse - 31059 - Toulouse 2972315 - France | Thibaud VALENTIN, MD | Contact (sur clinicalTrials) | |||
| Service d'oncologie/CHU de Besançon - Besançon 3033123 - France | Clément BOLOGNINI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
- Subject (male or female) with extra-peritoneal desmoid tumor (confirmed by prior
biopsy by an experienced pathologist within the RRePS network)
- 13 years of age or older
- Measurable viable tumor (according to the mRECIST criteria using MRI. The baseline
MRI imaging is mandatory in the 2 months prior to treatment initiation (D0).
- Progressive disease (according to the mRECIST criteria) after the watchful waiting
period or significant increase in symptoms requiring an active therapy, as advised
in a multidisciplinary sarcoma tumor board
- Tumor deemed accessible for cryoablation procedure by the operator in a type I
center. (In pediatric cases, a careful site tumor analysis will be performed with
interventional radiologist to ensure for limited consequence of cryoablation in
pediatric patients especially regarding growth plates).
- 100 % of destruction of the tumor achievable in one procedure of cryoablation with
1cm security margin according to assessment by referral center (type 1) for
cryoablation
- ECOG performance status 0-2 at inclusion visit
- Biological and hematological parameters (neutrophils ≥ 1,5.109/L ; platelet count ≥
100.109/L ; no significant hemostatic abnormalities) in the 4 weeks prior to
treatment initiation (D0)
- Subject able to understand the objectives and risks of the research and to give
dated and signed informed consent. For minors, the consent of the 2 parents must be
obtained.
- Subject affiliated to a social health insurance plan
- For a woman of childbearing age: negative blood pregnancy test at
screening/inclusion visit
- Subject agreeing to use a contraceptive method
Exclusion criteria:
- Intra-peritoneal or multifocal desmoid tumor
- Concurrent or prior use of any antitumor agent for the current desmoid tumor
- Relapse after surgery for desmoid tumor
- Any contraindication including known hypersensitivity to vinorelbine or other
vinca-alkaloids, or other constituents to navelbine, to vinblastine, to methotrexate
or any excipients, such as, but not limited to current or recent (within 2 weeks)
severe infection, severe renal failure, severe hepatic injury, chronic respiratory
failure
- Any contraindication including hypersensitivity to gadoteric acid, meglumine or any
drug containing gadolinium
- Concomitant treatment with: yellow fever vaccine, prophylactic treatment with
phenytoin, trimethoprim, ciprofloxacin, penicillins, probenecid, acetylsalicylic
acid, NSAIDs, PPIs, acitretin, azote protoxide, St John's wort
- Any contra-indication for the procedure as stated by the interventional radiologist
in terms of tumor size, proximity to neural/vascular structures or adjacent organs
at risk making the procedure at unacceptable risk
- Impaired hemostasis, that may interfere with the conduct of the cryoablation
- Contraindication to any form of sedation
- Others contra-indications to MRI
- Pregnancy or breastfeeding
- Concurrent participation in other experimental studies that could affect endpoints
of the present study
- Impossibility to give the subject informed information (subject in an emergency
situation, patient with comprehension difficulties ...)
- Psychiatric disorders
- Incompetent subject (subject to a legal protection measure: curatorship,
guardianship, future protection mandate, family habilitation)