NCT06081400招募中不适用
A Phase II Multicentric, Randomized Trial Assessing Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
University Hospital, Strasbourg, France13 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年3月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Rate of non-progressive disease
研究概览
简要总结
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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)
排除标准
- 未提供
研究组 & 干预措施
Cryoablation
Experimental
One single cryoablation of the desmoid tumor at Day 0
干预措施: Cryoablation (Procedure)
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
干预措施: Chemotherapy drug (Drug)
结局指标
主要结局
Rate of non-progressive disease
时间窗: 12 months after treatment initiation (Day 0+12months)
Rates of non-progressive disease (sum of complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST criteria)
次要结局
- 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)
- PAIN assessed by brief pain inventory (BPI) before and after treatment(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(Through study completion, up to 39 months)
- Progression-free survival 1(from treatment initiation to PD or 24 months whichever comes first)
- QUALITY OF LIFE assessed by EUROQOL EQ 5D before and after treatment(Screening visit, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12 after treatment initiation)
- Rate of complete response(12 months after treatment initiation and 12 months after cross-over)
- Rate of patients who cross over to the other arm(24 months after treatment initiation)
研究者
研究点 (13)
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