NCT06081400

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2024Jun 2029

First Submitted

Initial submission to the registry

August 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

August 31, 2023

Last Update Submit

November 14, 2025

Conditions

Desmoid Tumor

Keywords

DesmoidsCryoablationDrug therapyCross-Over Studies

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (8)

  • Progression-free survival 1

    from treatment initiation to PD or 24 months whichever comes first

  • Rate of patients who cross over to the other arm

    24 months after treatment initiation

  • Rate of complete response

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

  • Secondary Progression-free survival 2

    Through study completion, up to 39 months

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

    Through study completion, up to 39 months

  • +3 more secondary outcomes

Study Arms (2)

Cryoablation

EXPERIMENTAL

One single cryoablation of the desmoid tumor at Day 0

Procedure: Cryoablation

Medical therapy

ACTIVE COMPARATOR

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

Drug: Chemotherapy drug

Interventions

CryoablationPROCEDURE

Percutaneous imaging-guided cryoablation

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

Medical therapy

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject (male or female) with extra-peritoneal desmoid tumor (confirmed by prior biopsy by an experienced pathologist within the RRePS network)
  • 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).
  • % 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
  • 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
  • Subject agreeing to use a contraceptive method

You may not qualify 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Service d'oncologie/CHU de Besançon

Besançon, France

NOT YET RECRUITING

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

Bordeaux, 33000, France

RECRUITING

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

Caen, 14076, France

RECRUITING

Service d'Oncologie Médicale -Centre Georges François LECLERC

Dijon, 21079, France

RECRUITING

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

Lyon, 69373, France

RECRUITING

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

Marseille, 13385, France

RECRUITING

Service de Radiologie-CHU de Nantes

Nantes, 44000, France

RECRUITING

Service d'Oncologie Médicale-Centre Antoine LACASSAGNE

Nice, 06189, France

RECRUITING

Service d'Oncologie Médicale

Saint-Herblain, 44805, France

RECRUITING

Institut de cancérologie Strasbourg Europe (ICANS)

Strasbourg, 67033, France

RECRUITING

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

Strasbourg, 67091, France

RECRUITING

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

Toulouse, 31059, France

NOT YET RECRUITING

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

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Afshin GANGI, MD, PhD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Afshin GANGI, MD,PhD

CONTACT

0369550304afshin.gangi@chru-strasbourg.fr

Roberto Luigi CAZZATO, MD

CONTACT

0369550304RobertoLuigi.CAZZATO@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

October 13, 2023

Study Start

March 4, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2029

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

FR(13)