Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

Desmoid Tumor Clinical Trial

— CRYODESMO-02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081400
• Other study ID #: 7361
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: June 2029

Study information

• Verified date: March 2024
• Source: University Hospital, Strasbourg, France
• Contact: Afshin GANGI, MD,PhD
• Phone: 0369550304
• Email: afshin.gangi[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2029
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Desmoid Tumor

Intervention

Procedure:
• Cryoablation
Percutaneous imaging-guided cryoablation

Drug:
• Chemotherapy drug
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.

Locations

Country	Name	City	State
France	Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE	Bordeaux
France	Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE	Caen
France	Service d'Oncologie Médicale -Centre Georges François LECLERC	Dijon
France	Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD	Lyon
France	Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone	Marseille
France	Service de Radiologie-CHU de Nantes	Nantes
France	Service d'Oncologie Médicale-Centre Antoine LACASSAGNE	Nice
France	Service d'Oncologie Médicale-Centre Henri BECQUEREL	Rouen
France	Service d'Oncologie Médicale	Saint-Herblain
France	Institut de cancérologie Strasbourg Europe (ICANS)	Strasbourg
France	Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091	Strasbourg
France	Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse	Toulouse
France	Service d'Oncologie médicale, Service de Radiologie Interventionnelle- Institut Gustave ROUSSY	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Direction Générale de l'Offre des Soins (DGOS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	from treatment initiation to PD or 24 months whichever comes first
Secondary	Rate of patients who cross over to the other arm		24 months after treatment initiation
Secondary	Rate of complete response	Rate of complete response at 12 months in cryoablation and medical therapy group with and without a cross-over treatment	12 months after treatment initiation and 12 months after cross-over
Secondary	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	Through study completion, up to 39 months
Secondary	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	Through study completion, up to 39 months
Secondary	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)	Screening visit, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation
Secondary	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)	Screening visit, Day 0/Day 1, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation
Secondary	Health economics assessment	cost and incremental cost utility ratio	Through study completion, up to 39 months