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Compares treatment options for Desmoid Tumor
Official title Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
ClinicalTrials.gov ID: NCT06081400
What this study is testing
What is Chemotherapy drug?
Chemotherapy drug is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for desmoid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- "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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 and older
You may be able to join if
- 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...
- Progressive disease (according to the mRECIST criteria) after the watchful waiting period or significant increase in symptoms requiring an active...
- Tumor deemed accessible for cryoablation procedure by the operator in a type I center. (In pediatric cases, a careful site tumor analysis will be...
You likely can't join if
- 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...
- 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...
See the full eligibility 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 treatment radiologist to ensure for limited consequence of...
- 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
- 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...
- 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...
- Any contra-indication for the procedure as stated by the treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Caen, France
- Dijon, France
- Lyon, France
- Marseille, France
- Nantes, France
- Nice, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Caen, France; Dijon, France; Lyon, France; Marseille, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.