"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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Percutaneous imaging-guided cryoablation
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
Service d'oncologie/CHU de Besançon
Besançon, France
NOT_YET_RECRUITINGService d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
Bordeaux, France
RECRUITINGService d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
Caen, France
RECRUITINGService d'Oncologie Médicale -Centre Georges François LECLERC
Dijon, France
RECRUITINGService d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
Lyon, France
RECRUITINGService d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
Marseille, France
RECRUITINGService de Radiologie-CHU de Nantes
Nantes, France
RECRUITINGService d'Oncologie Médicale-Centre Antoine LACASSAGNE
Nice, France
RECRUITINGService d'Oncologie Médicale
Saint-Herblain, France
RECRUITINGInstitut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, France
RECRUITING...and 3 more locations
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)
Time frame: 12 months after treatment initiation (Day 0+12months)
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
Time frame: from treatment initiation to PD or 24 months whichever comes first
Rate of patients who cross over to the other arm
Time frame: 24 months after treatment initiation
Rate of complete response
Rate of complete response at 12 months in cryoablation and medical therapy group with and without a cross-over treatment
Time frame: 12 months after treatment initiation and 12 months after cross-over
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
Time frame: Through study completion, up to 39 months
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
Time frame: Through study completion, up to 39 months
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)
Time frame: Screening visit, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation
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)
Time frame: Screening visit, Day 0/Day 1, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation
Health economics assessment
cost and incremental cost utility ratio
Time frame: Through study completion, up to 39 months
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