Status:
RECRUITING
Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
Lead Sponsor:
University Hospital, Strasbourg, France
Collaborating Sponsors:
Direction Générale de l'Offre des Soins (DGOS)
Conditions:
Desmoid Tumor
Eligibility:
All Genders
13+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06081400
Start Date
March 4 2024
End Date
June 1 2029
Last Update
November 19 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Service d'oncologie/CHU de Besançon
Besançon, France
2
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
Bordeaux, France, 33000
3
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
Caen, France, 14076
4
Service d'Oncologie Médicale -Centre Georges François LECLERC
Dijon, France, 21079