A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
- Conditions
- DesmoidDesmoid TumorDesmoid Fibromatosis
- 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
- 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
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 FederationArtem GalustovContact9169117818artem115583@mail.ruAslan Valiev, PhDPrincipal InvestigatorDenis Sofronov, PhDSub Investigator