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Freeze or chemo? new trial tests a less harsh option for desmoid tumors

NCT ID NCT06081400

Disease control Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether freezing desmoid tumors with a needle (cryoablation) works better than standard chemotherapy for people whose tumors have grown after a period of watchful waiting. About 150 participants will be randomly assigned to one of the two treatments. If the tumor progresses on the first treatment, patients can switch to the other option. The goal is to see which approach better stops tumor growth with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cryoablation (a procedure that freezes and destroys tumor tissue) and chemotherapy drugs (methotrexate + vinblastine, or vinorelbine)
What this could lead to
If cryoablation works better than chemotherapy, it could offer a less toxic, more targeted way to control desmoid tumors without long-term medication.
What could go wrong
This is a phase 2 trial with only 150 participants, so results may not apply to everyone. Cryoablation may not work for all tumor locations or sizes, and there is a risk of side effects like pain or damage to nearby tissues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

desmoid tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Desmoid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institut de cancérologie Strasbourg Europe (ICANS)

    RECRUITING

    Strasbourg, 67033, France

  • Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091

    RECRUITING

    Strasbourg, 67091, France

  • Service d'Oncologie Médicale

    RECRUITING

    Saint-Herblain, 44805, France

  • Service d'Oncologie Médicale -Centre Georges François LECLERC

    RECRUITING

    Dijon, 21079, France

  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE

    RECRUITING

    Bordeaux, 33000, France

  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE

    RECRUITING

    Caen, 14076, France

  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD

    RECRUITING

    Lyon, 69373, France

  • Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone

    RECRUITING

    Marseille, 13385, France

  • Service d'Oncologie Médicale-Centre Antoine LACASSAGNE

    RECRUITING

    Nice, 06189, France

  • Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Service d'Oncologie médicale, Service de Radiologie Interventionnelle- Institut Gustave ROUSSY

    RECRUITING

    Villejuif, 94800, France

  • Service d'oncologie/CHU de Besançon

    NOT_YET_RECRUITING

    Besançon, France

  • Service de Radiologie-CHU de Nantes

    RECRUITING

    Nantes, 44000, France

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