A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
- Conditions
- DesmoidDesmoid TumorDesmoid Fibromatosis
- Interventions
- Procedure: radiofrequency ablation
- Registration Number
- NCT06355921
- Lead Sponsor
- Blokhin's Russian Cancer Research Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 27
- 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);
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Desmoid radiofrequency ablation Adult patients with desmoid tumors in the soft tissues of the extremities, trunk and paravertebral region of both sexes.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.
- Primary Outcome Measures
Name Time Method Comparison of safety assessment. 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 Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
- Secondary Outcome Measures
Name Time Method Overall Response Rate 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 Proportion of patients who have a partial or complete response to therapy
Duration of responce 3 years The time from randomization to disease progression or death for patients who achieve complete or partial alleviation
Comparison of tumor necrosis based on MRI/CT 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 Proportion of tumor necrosis after therapy
Trial Locations
- Locations (1)
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO)
🇷🇺Moscow, MO, Russian Federation