Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
NCT ID: NCT06081400
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-03-04
2029-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Cryoablation
One single cryoablation of the desmoid tumor at Day 0
Cryoablation
Percutaneous imaging-guided cryoablation
Medical therapy
Chemotherapy: at the investigator's discretion: 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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
13 Years
ALL
No
Sponsors
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Direction Générale de l'Offre des Soins (DGOS)
UNKNOWN
University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Afshin GANGI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Marie-Aude THENINT, MD
Role: primary
Alice HERVIEU, MD
Role: primary
Mehdi BRAHMI, MD
Role: primary
Florence DUFFAUD, MD, PhD
Role: primary
Arthur DAVID, MD
Role: primary
Agnès DUCOULOMBIER, MD
Role: primary
Emmanuelle BOMPAS, MD
Role: primary
Jean-Emmanuel KURTZ, MD PhD
Role: primary
Afshin GANGI, MD, PhD
Role: primary
Thibaud VALENTIN, MD
Role: primary
Frédéric DESCHAMPS, MD
Role: primary
Other Identifiers
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7361
Identifier Type: -
Identifier Source: org_study_id
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