Trial Title:
Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
NCT ID:
NCT06081400
Condition:
Desmoid Tumor
Conditions: Official terms:
Fibromatosis, Aggressive
Conditions: Keywords:
Desmoids
Cryoablation
Drug therapy
Cross-Over Studies
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cryoablation
Description:
Percutaneous imaging-guided cryoablation
Arm group label:
Cryoablation
Intervention type:
Drug
Intervention name:
Chemotherapy drug
Description:
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 90mg/week (per os: 3x30mg, soft
capsules) for 12 months.
Arm group label:
Medical therapy
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.
Criteria for 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)
Gender:
All
Minimum age:
13 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maud TOULMONDE, MD
Investigator:
Last name:
Maud TOULMONDE, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
Address:
City:
Caen
Zip:
14076
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marie-Aude THENINT, MD
Investigator:
Last name:
Marie-Aude THENINT, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale -Centre Georges François LECLERC
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alice HERVIEU, MD
Investigator:
Last name:
Alice HERVIEU, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mehdi BRAHMI, MD
Investigator:
Last name:
Mehdi BRAHMI, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
Address:
City:
Marseille
Zip:
13385
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Florence DUFFAUD, MD, PhD
Investigator:
Last name:
Florence DUFFAUD, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Service de Radiologie-CHU de Nantes
Address:
City:
Nantes
Zip:
44000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Arthur DAVID, MD
Investigator:
Last name:
Arthur DAVID, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale-Centre Antoine LACASSAGNE
Address:
City:
Nice
Zip:
06189
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Agnès DUCOULOMBIER, MD
Investigator:
Last name:
Agnès DUCOULOMBIER
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale-Centre Henri BECQUEREL
Address:
City:
Rouen
Zip:
76038
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cécile GUILLEMET, MD
Investigator:
Last name:
Cécile GUILLEMET, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie Médicale
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Emmanuelle BOMPAS, MD
Investigator:
Last name:
Emmnauelle BOMPAS, MD
Email:
Principal Investigator
Facility:
Name:
Institut de cancérologie Strasbourg Europe (ICANS)
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Emmanuel KURTZ, MD PhD
Investigator:
Last name:
Jean-Emmanuel KURTZ
Email:
Principal Investigator
Investigator:
Last name:
Sophie MARTIN
Email:
Sub-Investigator
Facility:
Name:
Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Contact:
Last name:
Afshin GANGI, MD, PhD
Investigator:
Last name:
Afshin GANGI, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Roberto Luigi CAZZATO, MD
Email:
Sub-Investigator
Investigator:
Last name:
Julien GARNON, MD PhD
Email:
Sub-Investigator
Facility:
Name:
Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Thibaud VALENTIN, MD
Investigator:
Last name:
Thibaud VALENTIN, MD
Email:
Principal Investigator
Facility:
Name:
Service d'Oncologie médicale, Service de Radiologie Interventionnelle- Institut Gustave ROUSSY
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frédéric DESCHAMPS, MD
Investigator:
Last name:
Frédéric DESCHAMPS, MD
Email:
Principal Investigator
Start date:
March 4, 2024
Completion date:
June 2029
Lead sponsor:
Agency:
University Hospital, Strasbourg, France
Agency class:
Other
Collaborator:
Agency:
Direction Générale de l'Offre des Soins (DGOS)
Agency class:
Other
Source:
University Hospital, Strasbourg, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081400
