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Desmoid TumorCRYODESMO-02NCT06081400

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

A study testing Cryoablation and Chemotherapy drug in people with Desmoid Tumor, run by University Hospital, Strasbourg, France at 13 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Cryoablation has proven to be beneficial for the treatment of large, progressive and symptomatic DT. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
Desmoid Tumor
What is being tested?
Cryoablation and Chemotherapy drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
13 sitesFrance
Study dates
4 Mar 2024to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Afshin GANGI, MD,PhD contact

0369550304 ext. 33

afshin.gangi@chru-strasbourg.fr

Roberto Luigi CAZZATO, MD contact

0369550304 ext. 33

RobertoLuigi.CAZZATO@chru-strasbourg.fr

13 sites in 1 country

France13 sites, 13 recruiting

  • Service d'oncologie/CHU de Besançon

    Besançon

    Clément BOLOGNINI, MD, cbolognini@chu-besancon.fr

    Not yet recruiting

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

    Bordeaux, 33000

    Maud TOULMONDE, MD, m.toulmonde@bordeaux.unicancer.fr

    Maud TOULMONDE, MD

    Recruiting

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

    Caen, 14076

    Marie-Aude THENINT, MD

    Marie-Aude THENINT, MD

    Recruiting

  • Service d'Oncologie Médicale -Centre Georges François LECLERC

    Dijon, 21079

    Alice HERVIEU, MD

    Alice HERVIEU, MD

    Recruiting

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

    Lyon, 69373

    Mehdi BRAHMI, MD

    Mehdi BRAHMI, MD

    Recruiting

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

    Marseille, 13385

    Florence DUFFAUD, MD, PhD

    Florence DUFFAUD, MD, PhD

    Recruiting

  • Service de Radiologie-CHU de Nantes

    Nantes, 44000

    Arthur DAVID, MD

    Arthur DAVID, MD

    Recruiting

  • Service d'Oncologie Médicale-Centre Antoine LACASSAGNE

    Nice, 06189

    Agnès DUCOULOMBIER, MD

    Agnès DUCOULOMBIER

    Recruiting

  • Service d'Oncologie Médicale

    Saint-Herblain, 44805

    Emmanuelle BOMPAS, MD

    Emmnauelle BOMPAS, MD

    Recruiting

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67033

    Jean-Emmanuel KURTZ, MD PhD

    Jean-Emmanuel KURTZ

    Recruiting

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

    Strasbourg, 67091

    Afshin GANGI, MD, PhD

    Afshin GANGI, MD, PhD

    Recruiting

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

    Toulouse, 31059

    Thibaud VALENTIN, MD

    Thibaud VALENTIN, MD

    Not yet recruiting

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

    Villejuif, 94800

    Frédéric DESCHAMPS, MD

    Frédéric DESCHAMPS, MD

    Recruiting

Other trials in France

About this study

Official title: A Phase II Multicentric, Randomized Trial Assessing Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

"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.

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.

Conditions
Desmoid Tumor
Being tested
Cryoablation, Chemotherapy drug
Keywords
Desmoids, Cryoablation, Drug therapy, Cross-Over Studies
Medical subject headings
Desmoid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryoablationProcedure or surgery

    Percutaneous imaging-guided cryoablation

  • Chemotherapy drugDrug

    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

Study groups in NCT06081400
Study groupRoleWhat they receive
CryoablationExperimentalOne single cryoablation of the desmoid tumor at Day 0
Receives: Procedure: Cryoablation
Medical therapyActive comparatorChemotherapy: 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
Receives: Drug: Chemotherapy drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of non-progressive disease

    Rates of non-progressive disease (sum of complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST criteria)

    Measured: 12 months after treatment initiation (Day 0+12months)

Secondary outcomes (8)

  1. Progression-free survival 1

    Progression-free survival 1 (PFS1: from the beginning of cryoablation or medical therapy to first disease progression) in cryoablation and medical therapy group

    Measured: from treatment initiation to PD or 24 months whichever comes first

  2. Rate of patients who cross over to the other arm

    Measured: 24 months after treatment initiation

  3. Rate of complete response

    Rate of complete response at 12 months in cryoablation and medical therapy group with and without a cross-over treatment

    Measured: 12 months after treatment initiation and 12 months after cross-over

  4. Secondary Progression-free survival 2

    Secondary Progression-free survival 2 (PFS 2: from the cross-over to second disease progression) in cryoablation and medical therapy group

    Measured: Through study completion, up to 39 months

  5. Incidence of Treatment-Emergent Adverse Events as assessed by NCI-CTCAE version 5.0 toxicity scale

    The occurrence of complications and adverse reactions according to the classification of the NCI-CTCAE version 5.0 toxicity scale

    Measured: Through study completion, up to 39 months

  6. QUALITY OF LIFE assessed by EUROQOL EQ 5D before and after treatment

    EUROQOL EQ 5D will be used; score ranging from 1 (good quality of life) to 5 (poor quality of life)

    Measured: Screening visit, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation

  7. PAIN assessed by brief pain inventory (BPI) before and after treatment

    BPI will be used; score ranging from 0 (no pain) to 10 (high pain)

    Measured: Screening visit, Day 0/Day 1, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation

  8. Health economics assessment

    cost and incremental cost utility ratio

    Measured: Through study completion, up to 39 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start4 Mar 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06081400
Sponsor's protocol ID
7361
Acronym
CRYODESMO-02
Status last verified
Nov 2025
First submitted
31 Aug 2023
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cryoablation and Chemotherapy drug in people with Desmoid Tumor, run by University Hospital, Strasbourg, France at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Afshin GANGI, MD,PhD (0369550304 ext. 33, afshin.gangi@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of non-progressive disease (time frame: 12 months after treatment initiation (Day 0+12months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06081400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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