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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:

• 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:

Locations
Other Locations
France
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
NOT_YET_RECRUITING
Bordeaux
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
NOT_YET_RECRUITING
Caen
Service d'Oncologie Médicale -Centre Georges François LECLERC
NOT_YET_RECRUITING
Dijon
Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
NOT_YET_RECRUITING
Lyon
Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
NOT_YET_RECRUITING
Marseille
Service de Radiologie-CHU de Nantes
NOT_YET_RECRUITING
Nantes
Service d'Oncologie Médicale-Centre Antoine LACASSAGNE
NOT_YET_RECRUITING
Nice
Service d'Oncologie Médicale-Centre Henri BECQUEREL
NOT_YET_RECRUITING
Rouen
Service d'Oncologie Médicale
NOT_YET_RECRUITING
Saint-herblain
Institut de cancérologie Strasbourg Europe (ICANS)
RECRUITING
Strasbourg
Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091
RECRUITING
Strasbourg
Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Service d'Oncologie médicale, Service de Radiologie Interventionnelle- Institut Gustave ROUSSY
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Afshin GANGI, MD,PhD
afshin.gangi@chru-strasbourg.fr
0369550304
Backup
Roberto Luigi CAZZATO, MD
RobertoLuigi.CAZZATO@chru-strasbourg.fr
0369550304
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2029-06
Participants
Target number of participants: 150
Treatments
Experimental: Cryoablation
One single cryoablation of the desmoid tumor at Day 0
Active_comparator: Medical therapy
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 90mg/week (per os: 3x30mg, soft capsules) for 12 months.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Strasbourg, France
Collaborators: Direction Générale de l'Offre des Soins (DGOS)

This content was sourced from clinicaltrials.gov