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Not yet recruiting NCT06355921

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

No phase Interventional Desmoid Tumor Desmoid Fibromatosis Desmoid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: radiofrequency ablation.
Who it may be relevant to
Registry conditions: Desmoid Tumor, Desmoid Fibromatosis, Desmoid. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Procedure 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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Overall Response Rate [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]
  • Duration of responce [Time frame: 3 years]
  • Comparison of tumor necrosis based on MRI/CT [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Onco — Moscow

Identifiers

NCT: NCT06355921 · RFAdesmoid

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗