Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Oct 6, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments for patients with desmoid tumors that have continued to grow after a "watchful waiting" period. The treatments being studied are cryoablation, a procedure that freezes and destroys the tumor, and medical therapy, which often includes chemotherapy. The goal is to see which treatment is more effective for managing these tumors. If you participate in the trial, you will have a chance to receive either treatment, and if necessary, you can switch to cryoablation later on.

To take part in this trial, you need to be at least 13 years old and have a confirmed diagnosis of an extra-peritoneal desmoid tumor that is growing or causing symptoms. You will need to meet certain health criteria, including having a measurable tumor and being in good overall health, as determined by your doctor. Participants can expect regular check-ups and imaging tests to monitor their condition. It's important to know that this trial is still recruiting patients, and everyone involved will be closely monitored to ensure safety and support throughout the process.

Gender

ALL

Eligibility criteria

• 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 desmoid tumor
• • Known hypersensitivity to vinorelbine or other vinca-alkaloids, or other constituents to navelbine, to vinblastine, to methotrexate or any excipients, current or recent (within 2 weeks) severe infection, severe renal failure, severe hepatic injury, chronic respiratory failure, concomitant treatment with: yellow fever vaccine, prophylactic treatment with phenytoin, trimethoprim, probenecid, acetylsalicylic acid, phenylbutazone.
• • 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
• • Concurrent participation in other experimental studies that could affect endpoints of the present study
• • Concurrent use of any antitumor agent or NSAIDs, penicillins, PPIs, acitretin, ciprofloxacin, azote protoxide
• • Contraindication to any form of sedation
• • Hypersensitivity to gadoteric acid, meglumine or any drug containing gadolinium
• • Others contra-indications to MRI
• • Pregnancy or breastfeeding
• • 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)