Desmoid, Desmoid Fibromatosis, Desmoid Tumor
Conditions
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.
Interventions
PROCEDUREradiofrequency 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 superficially located DFS, the skin is cooled during the procedure.
Sponsors
Blokhin's Russian Cancer Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with histologically verified diagnosis of dermoid tumor 2. The presence of progressive, symptomatic or functionally significant DF. 3. Written Informed consent to participate in the study 4. Age from 18 to 75 years 5. The functional status of the patient according to the ECOG 0-2 scale 6. Normal renal function (estimated creatinine clearance 60 ml/min); 7. Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms); 8. Left ventricular ejection fraction > 55% 9. Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count < 100 thousand/ml);
Exclusion criteria
1. The inability to obtain informed consent to participate in the study 2. Synchronous or metachronous cancer 3. Clinically significant diseases of the cardiovascular system 4. Clinically significant CNS diseases 5. Previous grade 2 polyneuropathy and above 6. Current infection or other severe or systemic disease that increases the risk of complications of therapy 7. Pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Russia
Contacts
Primary ContactArtem Galustov
Outcome results
None listed