A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Desmoid Tumor
- Sponsor
- Blokhin's Russian Cancer Research Center
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Comparison of safety assessment.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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);
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Comparison of safety assessment.
Time Frame: 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 Outcomes
- 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)
- Duration of responce(3 years)
- 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)