A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors

Обзор

This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors. In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month. In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.

Вмешательства

• Процедура radiofrequency ablation
  Anesthesia: Local (Novocaine, Lidocaine, Bupivacaine) Access: transcutaneous Navigation under CT control Cannulas are used: 22G 100 and 150 mm, the size of the electrode corresponds to the size of the cannula The starting power is 20W followed by steps of 10W every 2 minutes until the maximum power is reached, the maximum power is 60W. In order to prevent infectious complications, two-day antibiotic prophylaxis of Cefazolin (1g) is carried out 3 times a day In order to prevent skin burns with s

Первичные конечные точки

• Comparison of safety assessment. [Срок оценки: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy]

Вторичные конечные точки (3)

• Overall Response Rate [Срок оценки: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy]
• Duration of responce [Срок оценки: 3 years]
• Comparison of tumor necrosis based on MRI/CT [Срок оценки: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy]

Критерии участия

Критерии включения

• Patients with histologically verified diagnosis of dermoid tumor
• The presence of progressive, symptomatic or functionally significant DF.
• Written Informed consent to participate in the study
• Age from 18 to 75 years
• The functional status of the patient according to the ECOG 0-2 scale
• Normal renal function (estimated creatinine clearance 60 ml/min);
• Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);
• Left ventricular ejection fraction \> 55%
• Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count \< 100 thousand/ml);

Критерии исключения

• The inability to obtain informed consent to participate in the study
• Synchronous or metachronous cancer
• Clinically significant diseases of the cardiovascular system
• Clinically significant CNS diseases
• Previous grade 2 polyneuropathy and above
• Current infection or other severe or systemic disease that increases the risk of complications of therapy
• Pregnancy, lactation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Onco — Moscow

Идентификаторы

NCT: NCT06355921 · RFAdesmoid

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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