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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBlokhin's Russian Cancer Research Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • radiofrequency ablation

    Procedure/Surgery

    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.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: DesmoidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of safety assessment.

Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

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 outcomes

1

Overall Response Rate

Proportion of patients who have a partial or complete response to therapy

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
2

Duration of responce

The time from randomization to disease progression or death for patients who achieve complete or partial alleviation

Time frame
3 years
3

Comparison of tumor necrosis based on MRI/CT

Proportion of tumor necrosis after therapy

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

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) Status unavailable 115522, Moscow, Moscow OblastRussiaRussia

Sponsors and contacts

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